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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K881083
Device Name GENERAL PURPOSE KIT
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 Number878.4370
Classification Product Code
LRO  
Date Received03/14/1988
Decision Date 04/07/1988
Decision Substantially Equivalent - With Drug (SESD)
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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