The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Cordguard Ii.
| Device ID | K954619 |
| 510k Number | K954619 |
| Device Name: | CORDGUARD II |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| 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 | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-05 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671CRD2011 | K954619 | 000 |