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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name brush, biopsy, general & plastic surgery
510(k) Number K841008
Device Name BIOPSY PUNCH, VARIOUS
Applicant
PREMIER DENTAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PREMIER DENTAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GEE  
Date Received03/09/1984
Decision Date 06/08/1984
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
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