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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 K905854
Device Name CONDOMS
Applicant
BARNETTS, INC.
3630 TRYCLAN DR.
CHARLOTTE,  NC  28217
Applicant Contact J. M BARNETT
Correspondent
BARNETTS, INC.
3630 TRYCLAN DR.
CHARLOTTE,  NC  28217
Correspondent Contact J. M BARNETT
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/18/1990
Decision Date 02/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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