Document Detail

Medical devices; general and plastic surgery devices; classification of the nonabsorbable expandable hemostatic sponge for temporary internal use. Final order.
MedLine Citation:
PMID:  25011158     Owner:  HSR     Status:  In-Process    
The Food and Drug Administration (FDA) is classifying the nonabsorbable expandable hemostatic sponge for temporary internal use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the nonabsorbable expandable hemostatic sponge for temporary internal use classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  79     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2014 Jun 
Date Detail:
Created Date:  2014-07-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  34222-4     Citation Subset:  T    
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