The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Electrosurgical Flexible Electrode In-line Suction Coagulator.
| Device ID | K944012 |
| 510k Number | K944012 |
| Device Name: | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles M Hart |
| Correspondent | Charles M Hart ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-12-21 |