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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K933265
Device Name ACU-DISPO-CE(TM)
Applicant
Acuderm, Inc.
5370 NW 35th Terrace
Ft. Lauderdale,  FL  33309
Applicant Contact CHARLES R YEH
Correspondent
Acuderm, Inc.
5370 NW 35th Terrace
Ft. Lauderdale,  FL  33309
Correspondent Contact CHARLES R YEH
Regulation Number878.4800
Classification Product Code
MDM  
Date Received07/06/1993
Decision Date 03/07/1994
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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