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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 K854541
Device Name TIP OFF FORCEPS
Applicant
KELLER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Applicant Contact EUGENE VANARSDALE
Correspondent
KELLER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Correspondent Contact EUGENE VANARSDALE
Regulation Number878.4800
Classification Product Code
GEN  
Date Received11/13/1985
Decision Date 12/17/1985
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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