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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 K874135
Device Name CONDOM (PROPHYLACTIC)
Applicant
Pactec, Inc.
4 Nickerson St.
Seattle,  WA  98109
Applicant Contact I MARIESKIND
Correspondent
Pactec, Inc.
4 Nickerson St.
Seattle,  WA  98109
Correspondent Contact I MARIESKIND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/13/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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