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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Dermabrasion, Powered
510(k) Number K963204
Device Name DMS-1000C DERMOABRADER
Applicant
Aesthetic Lasers, Inc.
528 College Pkwy., Suite C-1
Annapolis,  MD  21401
Applicant Contact FRED DE JACMA
Correspondent
Aesthetic Lasers, Inc.
528 College Pkwy., Suite C-1
Annapolis,  MD  21401
Correspondent Contact FRED DE JACMA
Regulation Number878.4820
Classification Product Code
GFE  
Subsequent Product Code
GFD  
Date Received08/15/1996
Decision Date 12/09/1996
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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