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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 K933137
Device Name ACU-SUTURE KIT
Applicant
Acuderm, Inc.
5370 NW 35th Ter.
Ft. Lauderdale,  FL  33309
Applicant Contact CHARLES YEH
Correspondent
Acuderm, Inc.
5370 NW 35th Ter.
Ft. Lauderdale,  FL  33309
Correspondent Contact CHARLES YEH
Regulation Number878.4370
Classification Product Code
LRO  
Date Received06/28/1993
Decision Date 02/22/1994
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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