The following data is part of a premarket notification filed by Euro-med Intl. with the FDA for Atlantic Grasper.
| Device ID | K854898 |
| 510k Number | K854898 |
| Device Name: | ATLANTIC GRASPER |
| Classification | Instrument, Surgical, Disposable |
| Applicant | EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville, CA 94526 |
| Contact | Donald Holsten |
| Correspondent | Donald Holsten EURO-MED INTL. ADVANCED BIOSEARCH ASSOCIATES 3880 BLACKHAWK ROAD Danville, CA 94526 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-05-02 |