The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Fowler Endocurette, Model Cur-xxx.
| Device ID | K000974 |
| 510k Number | K000974 |
| Device Name: | FOWLER ENDOCURETTE, MODEL CUR-XXX |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| 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 | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671CUR1201 | K000974 | 000 |
| H671CUR1001 | K000974 | 000 |