The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Intran Plus.
| Device ID | K955443 |
| 510k Number | K955443 |
| Device Name: | INTRAN PLUS |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Kevin L Cornwell |
| Correspondent | Kevin L Cornwell UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671IUP6501 | K955443 | 000 |
| H671IUP6001 | K955443 | 000 |
| H671IUP4501 | K955443 | 000 |
| H671IUP4001 | K955443 | 000 |