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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Surgical, General Use
510(k) Number K891334
Device Name ACU-CURETTE
Applicant
Acuderm, Inc.
5370 NW 35th Ter.
Ft. Lauderdale,  FL  33309
Applicant Contact CHARLES R YEH
Correspondent
Acuderm, Inc.
5370 NW 35th Ter.
Ft. Lauderdale,  FL  33309
Correspondent Contact CHARLES R YEH
Regulation Number878.4800
Classification Product Code
FZS  
Date Received03/10/1989
Decision Date 04/11/1989
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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