The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Uterine Manipulator Injector, Model Umi 4.5.
| Device ID | K092980 |
| 510k Number | K092980 |
| Device Name: | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 |
| 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 | 2010-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309122846 | K092980 | 000 |
| 04719894432885 | K092980 | 000 |
| 00812171027539 | K092980 | 000 |
| 00842962101322 | K092980 | 000 |
| 00842962101469 | K092980 | 000 |
| 00842962101476 | K092980 | 000 |
| 00842962101483 | K092980 | 000 |
| 00842962103395 | K092980 | 000 |
| 00842962103401 | K092980 | 000 |
| 00842962103418 | K092980 | 000 |
| 04715309122877 | K092980 | 000 |
| 04715309122884 | K092980 | 000 |
| 04715309121948 | K092980 | 000 |
| 04715309122440 | K092980 | 000 |
| 04715309122839 | K092980 | 000 |
| 04719894432953 | K092980 | 000 |