The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Bellota Sonohysterography Catheter With Cervical Cone, Bellota Sonohysterography Catheter Without Cervical Cone.
| Device ID | K102898 |
| 510k Number | K102898 |
| Device Name: | BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE |
| 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 | 2010-09-30 |
| Decision Date | 2011-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309123843 | K102898 | 000 |
| 04719894432793 | K102898 | 000 |
| 04719894432809 | K102898 | 000 |
| 00812171023906 | K102898 | 000 |
| 00842962100189 | K102898 | 000 |
| 00842962105245 | K102898 | 000 |
| 10842962105242 | K102898 | 000 |
| 04715309121900 | K102898 | 000 |
| 04715309121979 | K102898 | 000 |
| 04719894432786 | K102898 | 000 |