The following data is part of a premarket notification filed by American Bentley with the FDA for Electrosurgical Meniscus Cutter (emc) Mod. Amc-100.
| Device ID | K870269 |
| 510k Number | K870269 |
| Device Name: | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY P.O. BOX 19522 Irvine, CA 92713 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-23 |
| Decision Date | 1987-03-09 |