| Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule. | |
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MedLine Citation:
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PMID: 21351681 Owner: HSR Status: In-Process |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 76 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2011 Feb |
Date Detail:
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Created Date: 2011-02-25 Completed Date: - Revised Date: - |
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: 6551-3 Citation Subset: T |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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