| Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule. | |
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MedLine Citation:
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PMID: 11067714 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 65 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2000 Aug |
Date Detail:
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Created Date: 2000-10-26 Completed Date: 2000-10-26 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 48609-12 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval* Equipment Design Equipment Safety Gastroenterology / classification, instrumentation* Humans Lithotripsy / classification, instrumentation* United States United States Food and Drug Administration Urology / classification, instrumentation* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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