The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Biopsy Forceps Fb-456d.
| Device ID | K200397 |
| 510k Number | K200397 |
| Device Name: | Single Use Biopsy Forceps FB-456D |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Jonathan Gilbert Olympus Coprporation Of The Americas 3500 Corporation Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170411936 | K200397 | 000 |