The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Accushear Laparoscopic Surgical Instruments.
| Device ID | K982984 |
| 510k Number | K982984 |
| Device Name: | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROLINE PENTAX, INC. 70 WALNUT ST. Wellesley, MA 02481 -2102 |
| Contact | Jacqueline E Masse |
| Correspondent | Jacqueline E Masse MICROLINE PENTAX, INC. 70 WALNUT ST. Wellesley, MA 02481 -2102 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-26 |
| Decision Date | 1998-10-21 |
| Summary: | summary |