The following data is part of a premarket notification filed by Aragon Surgical Inc. with the FDA for Aragon Oneshot System.
| Device ID | K081312 |
| 510k Number | K081312 |
| Device Name: | ARAGON ONESHOT SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B Palo Alto, CA 94303 |
| Contact | Alan Curtis |
| Correspondent | Alan Curtis ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B Palo Alto, CA 94303 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-09 |
| Decision Date | 2008-10-31 |
| Summary: | summary |