The following data is part of a premarket notification filed by Falcon Instruments, Inc. with the FDA for Disposable Forceps, Hemostats, Needle Guides, Etc.
Device ID | K930775 |
510k Number | K930775 |
Device Name: | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC |
Classification | Instrument, Manual, Surgical, General Use |
Applicant | FALCON INSTRUMENTS, INC. P.O. BOX 3738 Arlington, VA 22203 |
Contact | Ismail |
Correspondent | Ismail FALCON INSTRUMENTS, INC. P.O. BOX 3738 Arlington, VA 22203 |
Product Code | MDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-16 |
Decision Date | 1993-04-23 |