The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Graspers.
| Device ID | K935382 |
| 510k Number | K935382 |
| Device Name: | GRASPERS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Contact | Charles E Allgood, Jr |
| Correspondent | Charles E Allgood, Jr MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-02-15 |