The following data is part of a premarket notification filed by U.a. Medical Products, Inc. with the FDA for Endometrial Sampler.
| Device ID | K990387 |
| 510k Number | K990387 |
| Device Name: | ENDOMETRIAL SAMPLER |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | U.A. MEDICAL PRODUCTS, INC. 9303-G2 MONROE RD. Charlotte, NC 28270 |
| Contact | Fanish Engineer |
| Correspondent | Fanish Engineer U.A. MEDICAL PRODUCTS, INC. 9303-G2 MONROE RD. Charlotte, NC 28270 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-08 |
| Decision Date | 1999-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852073002750 | K990387 | 000 |
| B296820010 | K990387 | 000 |
| B29682000 | K990387 | 000 |