The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Endometrial Sampler.
| Device ID | K872908 |
| 510k Number | K872908 |
| Device Name: | ENDOMETRIAL SAMPLER |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 6311 DESOTO AVENUE, SUITE M Woodland Hills, CA 91367 |
| Contact | Thomas J Zinnanti |
| Correspondent | Thomas J Zinnanti ZINNANTI SURGICAL INSTRUMENTS, INC. 6311 DESOTO AVENUE, SUITE M Woodland Hills, CA 91367 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-24 |
| Decision Date | 1987-10-20 |