The following data is part of a premarket notification filed by Thomas Medical, Inc. with the FDA for Uterine Injector.
| Device ID | K022503 |
| 510k Number | K022503 |
| Device Name: | UTERINE INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | THOMAS MEDICAL, INC. 4100-C NINE MCFARLAND DR. Alpharetta, GA 30004 |
| Contact | Thomas J Zinnanti |
| Correspondent | Thomas J Zinnanti THOMAS MEDICAL, INC. 4100-C NINE MCFARLAND DR. Alpharetta, GA 30004 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2002-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNX101601 | K022503 | 000 |