The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Uterine Inector, Model Ui-4.0, Ui-2.0.
| Device ID | K092984 |
| 510k Number | K092984 |
| Device Name: | PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Contact | Yen-ming Pan |
| Correspondent | Yen-ming Pan Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309121962 | K092984 | 000 |
| 04715309121955 | K092984 | 000 |
| 04719894433011 | K092984 | 000 |