The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fg Series Of Rat Tooth Grasping Forceps.
Device ID | K955051 |
510k Number | K955051 |
Device Name: | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS |
Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Subhash Patel |
Correspondent | Subhash Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | OCZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-06 |
Decision Date | 1996-01-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170032445 | K955051 | 000 |
14953170032414 | K955051 | 000 |
14953170032384 | K955051 | 000 |