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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 K945246
Device Name PREVENTOR AND PROTECTOR LATEX CONDOMS
Applicant
AMERICAN PHARMACEUTICAL CO., INC.
200 WEBRO RD.
PARSIPPANY,  NJ  07054
Applicant Contact ALFRED C BAGWELL
Correspondent
AMERICAN PHARMACEUTICAL CO., INC.
200 WEBRO RD.
PARSIPPANY,  NJ  07054
Correspondent Contact ALFRED C BAGWELL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/27/1994
Decision Date 09/07/1995
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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