PANPAC HSG CATHETER SET

Cannula, Manipulator/injector, Uterine

Panpac Medical Corporation

The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Hsg Catheter Set.

Pre-market Notification Details

Device IDK092983
510k NumberK092983
Device Name:PANPAC HSG CATHETER SET
ClassificationCannula, Manipulator/injector, Uterine
Applicant Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien,  TW 22103
ContactYen-ming Pan
CorrespondentYen-ming Pan
Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien,  TW 22103
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-28
Decision Date2010-06-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.