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 |