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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 K904840
Device Name ORION PLUS/MODIFICATION
Applicant
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Applicant Contact DAVID P MAYER
Correspondent
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Correspondent Contact DAVID P MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/24/1990
Decision Date 11/20/1990
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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