The following data is part of a premarket notification filed by Coral Medical, Inc. with the FDA for Model Pbd Esu Pencil.
| Device ID | K944363 |
| 510k Number | K944363 |
| Device Name: | MODEL PBD ESU PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CORAL MEDICAL, INC. 5765 S. MONACO ST. Englewood, CO 80111 |
| Contact | Richard P Fleenor |
| Correspondent | Richard P Fleenor CORAL MEDICAL, INC. 5765 S. MONACO ST. Englewood, CO 80111 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1994-12-05 |