The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Filtresse, Smoke Filtration System, 115 Vac & 230 Vac.
| Device ID | K952981 |
| 510k Number | K952981 |
| Device Name: | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | John W Smith |
| Correspondent | John W Smith UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1995-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671SSE1000 | K952981 | 000 |
| H671SSE2000 | K952981 | 000 |