BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE

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 Bellota Sonohysterography Catheter With Cervical Cone, Bellota Sonohysterography Catheter Without Cervical Cone.

Pre-market Notification Details

Device IDK102898
510k NumberK102898
Device Name:BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
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 Received2010-09-30
Decision Date2011-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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