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 |