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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous, Biopsy
510(k) Number K933324
Device Name SKIN BIOPSY DEVICE
Applicant
Nhr, Inc.
1314 Macomb
Monroe,  MI 
Applicant Contact HOSSEIN NABAI
Correspondent
Nhr, Inc.
1314 Macomb
Monroe,  MI 
Correspondent Contact HOSSEIN NABAI
Regulation Number878.4800
Classification Product Code
MJG  
Date Received07/12/1993
Decision Date 03/31/1994
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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