The following data is part of a premarket notification filed by Falcon Instruments, Inc. with the FDA for Disposable Forceps.
Device ID | K920296 |
510k Number | K920296 |
Device Name: | DISPOSABLE FORCEPS |
Classification | Instrument, Manual, Surgical, General Use |
Applicant | FALCON INSTRUMENTS, INC. 8309 BRYANT DR. Bethesda, MD 20817 |
Contact | Neal Dunning |
Correspondent | Neal Dunning FALCON INSTRUMENTS, INC. 8309 BRYANT DR. Bethesda, MD 20817 |
Product Code | MDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-22 |
Decision Date | 1992-09-11 |