The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Laprascopic Grasper.
| Device ID | K944062 |
| 510k Number | K944062 |
| Device Name: | LAPRASCOPIC GRASPER |
| Classification | Endoscope, Battery-powered And Accessories |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Brenda Sparks |
| Correspondent | Brenda Sparks INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | GCS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1995-02-23 |