Document Detail


Medical devices; ophthalmic devices; classification of the eyelid thermal pulsation system. Final rule.
MedLine Citation:
PMID:  21894651     Owner:  HSR     Status:  In-Process    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). 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.
Authors:
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  76     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-09-06     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  51876-8     Citation Subset:  T    
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