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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 K884469
Device Name ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
Applicant
MAYER LABORATORIES
1611 TELEGRAPH AVENUE, SUITE
830
OAKLAND,  CA  94612
Applicant Contact DAVID P MAYER
Correspondent
MAYER LABORATORIES
1611 TELEGRAPH AVENUE, SUITE
830
OAKLAND,  CA  94612
Correspondent Contact DAVID P MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/25/1988
Decision Date 03/31/1989
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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