The following data is part of a premarket notification filed by Olympus Optical, Co. with the FDA for Hx-5/6-1 Endoscopic Clipping Device, Endoscopic Clips.
| Device ID | K990687 |
| 510k Number | K990687 |
| Device Name: | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OLYMPUS OPTICAL, CO. 2 CORPORATE CENTER Melville, NY 11747 |
| Contact | Laura Storms Tyler |
| Correspondent | Laura Storms Tyler OLYMPUS OPTICAL, CO. 2 CORPORATE CENTER Melville, NY 11747 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-03-26 |
| Summary: | summary |