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 |