FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

TIP OFF FORCEPS

K Number: K854541 · Decision Dec 17, 1985
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
103
Applicant Total
5
Review Days
34

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Basic Information

Device Name
TIP OFF FORCEPS
K Number
K854541
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Keller Instruments, Inc.
Date Received
November 13, 1985
Decision Date
December 17, 1985
Product Code
GEN
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEN Forceps, General & Plastic Surgery

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Other Clearances by Keller Instruments, Inc.

K Number Device Name
K841294 ACU220 CRYO UNIT
K841292 SPECTACLE INDIRECT OPHTHALMOSCOPE
K841293 PANORAMIC LOUPES - VARIOUS
K823835 SPEMBLY 140 CRYOSYSTEM PROBES & TIPS