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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K984488
Device Name SHEER THIN
Applicant
TWE COMPANIES, INC.
46 FRANKLIN ST.
AVONDALE ESTATES,  GA  30002
Applicant Contact KEITH F HEINTZ
Correspondent
TWE COMPANIES, INC.
46 FRANKLIN ST.
AVONDALE ESTATES,  GA  30002
Correspondent Contact KEITH F HEINTZ
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/17/1998
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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