The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Uterine Injector 2mm.
| Device ID | K873515 |
| 510k Number | K873515 |
| Device Name: | UTERINE INJECTOR 2MM |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (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 | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-09-29 |