The following data is part of a premarket notification filed by Wilson Greatbatch Technologies, Inc. with the FDA for Wgl Endoscopic Grasper*.
| Device ID | K950063 |
| 510k Number | K950063 |
| Device Name: | WGL ENDOSCOPIC GRASPER* |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WILSON GREATBATCH TECHNOLOGIES, INC. 10,000 WEHRLE DR. Clarence, NY 14031 |
| Contact | Colin P Hart |
| Correspondent | Colin P Hart WILSON GREATBATCH TECHNOLOGIES, INC. 10,000 WEHRLE DR. Clarence, NY 14031 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-06 |
| Decision Date | 1995-01-27 |