The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Endometrial Pipelle.
| Device ID | K854415 |
| 510k Number | K854415 |
| Device Name: | ENDOMETRIAL PIPELLE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Anthony Hemming |
| Correspondent | Anthony Hemming UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-04 |
| Decision Date | 1986-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937011120 | K854415 | 000 |
| 00888937003475 | K854415 | 000 |