The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Utah Essu.
| Device ID | K905263 |
| 510k Number | K905263 |
| Device Name: | UTAH ESSU |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Edwin O Goodman |
| Correspondent | Edwin O Goodman 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 | 1990-11-23 |
| Decision Date | 1991-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671DBL3112 | K905263 | 000 |
| H671DLPM052 | K905263 | 000 |
| H671DLPM112 | K905263 | 000 |
| H671DLPN052 | K905263 | 000 |
| H671DLPN112 | K905263 | 000 |
| H671DLPS052 | K905263 | 000 |
| H671DLPS112 | K905263 | 000 |
| H671DLPSQ12 | K905263 | 000 |
| H671DLPSQ22 | K905263 | 000 |
| H671DLPL112 | K905263 | 000 |
| H671DLPE112 | K905263 | 000 |
| H671DBL5051 | K905263 | 000 |
| H671DBL5112 | K905263 | 000 |
| H671DCE1102 | K905263 | 000 |
| H671DCE1152 | K905263 | 000 |
| H671DCE1202 | K905263 | 000 |
| H671DCE1252 | K905263 | 000 |
| H671DLPB052 | K905263 | 000 |
| H671DLPB112 | K905263 | 000 |
| H671DLPSQ32 | K905263 | 000 |
| H671DLPT052 | K905263 | 000 |
| H671DLPT112 | K905263 | 000 |
| H671DN03452 | K905263 | 000 |
| H671DN04002 | K905263 | 000 |
| H671DN04452 | K905263 | 000 |
| H671DN08002 | K905263 | 000 |
| H671DN08102 | K905263 | 000 |
| H671DXTL092 | K905263 | 000 |
| H671DXTS062 | K905263 | 000 |
| H671ESU3052 | K905263 | 000 |
| H671DN03002 | K905263 | 000 |
| H671DN02452 | K905263 | 000 |
| H671DLPU052 | K905263 | 000 |
| H671DLPU112 | K905263 | 000 |
| H671DLPW112 | K905263 | 000 |
| H671DLPX102 | K905263 | 000 |
| H671DLS1001 | K905263 | 000 |
| H671DLS2001 | K905263 | 000 |
| H671DLS3001 | K905263 | 000 |
| H671DN02002 | K905263 | 000 |
| H671ESU3062 | K905263 | 000 |