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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 K874383
Device Name MENTOR PLUS (CONDOM)
Applicant
Arcon Corp.
1421 2nd. Ave. Nw.
Stewartville,  MN  55976
Applicant Contact RICHARD FRYAR
Correspondent
Arcon Corp.
1421 2nd. Ave. Nw.
Stewartville,  MN  55976
Correspondent Contact RICHARD FRYAR
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/26/1987
Decision Date 03/07/1988
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
Recalls CDRH Recalls
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