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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 K925653
Device Name DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH
Applicant
Dermatopathology Laboratory
21 Victoria Ave.
Castle Hill
New South Wales,Australia,  AU
Applicant Contact JOHN PARSONAGE
Correspondent
Dermatopathology Laboratory
21 Victoria Ave.
Castle Hill
New South Wales,Australia,  AU
Correspondent Contact JOHN PARSONAGE
Regulation Number878.4800
Classification Product Code
MDM  
Date Received11/09/1992
Decision Date 11/08/1993
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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