The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Aspiration/coagulation Electrode Ace-311 & Ace-511.
| Device ID | K955093 |
| 510k Number | K955093 |
| Device Name: | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Jonh W Smith |
| Correspondent | Jonh W Smith UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1996-04-29 |
| Summary: | summary |