The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Sun Medical Smoke Evacuator System.
| Device ID | K874948 |
| 510k Number | K874948 |
| Device Name: | SUN MEDICAL SMOKE EVACUATOR SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
| Contact | Howard Penney |
| Correspondent | Howard Penney SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1988-02-18 |