Panpac Disposable Pessary Fitting Set

Pessary, Vaginal

Panpac Medical Corporation

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

Pre-market Notification Details

Device IDK153422
510k NumberK153422
Device Name:Panpac Disposable Pessary Fitting Set
ClassificationPessary, Vaginal
Applicant Panpac Medical Corporation 6F-1,2, NO. 202, SEC.3 TA-TONG ROAD Shi-chih District,  TW 22103
ContactYen-ming Pan
CorrespondentYen-ming Pan
Panpac Medical Corporation 6F-1,2, NO. 202, SEC.3 TA-TONG ROAD Shi-chih District,  TW 22103
Product CodeHHW  
CFR Regulation Number884.3575 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-25
Decision Date2016-07-14

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