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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, general & plastic surgery
510(k) Number K853015
Device Name SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
Applicant
THE HUXLEY INSTRUMENT CORP.
215 MAIN ST.
PENN YAN,  NY  14527
Applicant Contact REBECCA J SHAHZADA
Correspondent
THE HUXLEY INSTRUMENT CORP.
215 MAIN ST.
PENN YAN,  NY  14527
Correspondent Contact REBECCA J SHAHZADA
Regulation Number878.4800
Classification Product Code
GEN  
Date Received07/17/1985
Decision Date 07/29/1985
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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