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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Surgical, General & Plastic Surgery
510(k) Number K881084
Device Name UTILITY CLAMP
Applicant
Med-Dex Intl.
Suite #237
4790 Irvine Blvd. #105
Irvine,  CA  92714
Applicant Contact DIANE MOMODA-MADISON
Correspondent
Med-Dex Intl.
Suite #237
4790 Irvine Blvd. #105
Irvine,  CA  92714
Correspondent Contact DIANE MOMODA-MADISON
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received03/14/1988
Decision Date 03/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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