GFI · Class I · 21 CFR 878.4800

FDA Product Code GFI: Osteotome, Manual

Leading manufacturers include Storz Instrument Co., Zinnanti Surgical Instruments, Inc. and Biomerieux Vitek, Inc..

6
Total
6
Cleared
89d
Avg days
1984
Since

FDA 510(k) Cleared Osteotome, Manual Devices (Product Code GFI)

6 devices
1–6 of 6
Cleared Nov 02, 1993
VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500
K933181
Valleylab, Inc.
General & Plastic Surgery · 125d
Cleared Sep 25, 1992
HEMOLAB SILIMAT REAGENT
K920001
Biomerieux Vitek, Inc.
Hematology · 267d
Cleared Apr 12, 1989
OSTEOTOMES, VARIOUS TYPES
K891887
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 19d
Cleared Jul 11, 1985
STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
K852541
Storz Instrument Co.
General & Plastic Surgery · 27d

About Product Code GFI - Regulatory Context