The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Electrosurgical Hemostatic Forceps Series.
| Device ID | K062517 |
| 510k Number | K062517 |
| Device Name: | ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES |
| Classification | Forceps, Biopsy, Electric |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170359801 | K062517 | 000 |
| 14953170251549 | K062517 | 000 |
| 14953170251532 | K062517 | 000 |
| 14953170208437 | K062517 | 000 |
| 14953170037709 | K062517 | 000 |
| 14953170035453 | K062517 | 000 |
| 14953170035415 | K062517 | 000 |