The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Hsg Catheter Set.
| Device ID | K092983 |
| 510k Number | K092983 |
| Device Name: | PANPAC HSG CATHETER SET |
| 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 | 2010-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309121931 | K092983 | 000 |
| 04719894432649 | K092983 | 000 |
| 04719894432656 | K092983 | 000 |
| 04719894432663 | K092983 | 000 |
| 04719894432670 | K092983 | 000 |
| 04719894432687 | K092983 | 000 |
| 00812171023920 | K092983 | 000 |
| 00812171023937 | K092983 | 000 |
| 00842962100080 | K092983 | 000 |
| 00842962100097 | K092983 | 000 |
| 00842962105269 | K092983 | 000 |
| 00842962105276 | K092983 | 000 |
| 10842962105266 | K092983 | 000 |
| 10842962105273 | K092983 | 000 |
| 04713025224011 | K092983 | 000 |
| 04715309121887 | K092983 | 000 |
| 04715309121894 | K092983 | 000 |
| 04715309121924 | K092983 | 000 |
| 04719894432632 | K092983 | 000 |