The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Aspirette Endocervical Aspirator.
| Device ID | K895403 |
| 510k Number | K895403 |
| Device Name: | ASPIRETTE ENDOCERVICAL ASPIRATOR |
| Classification | Aspirator, Endocervical |
| 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 | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-07 |
| Decision Date | 1989-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003486 | K895403 | 000 |