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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K881338
Device Name CONDOM-MATE VAGINAL LUBRICANT
Applicant
Upsher-Smith Laboratories, Inc.
14905 23rd Ave. N.
Minneapolis,  MN  55447
Applicant Contact HARVEY M ARBIT
Correspondent
Upsher-Smith Laboratories, Inc.
14905 23rd Ave. N.
Minneapolis,  MN  55447
Correspondent Contact HARVEY M ARBIT
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received03/29/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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