The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Disposable Pessary Fitting Set.
Device ID | K153422 |
510k Number | K153422 |
Device Name: | Panpac Disposable Pessary Fitting Set |
Classification | Pessary, Vaginal |
Applicant | Panpac Medical Corporation 6F-1,2, NO. 202, SEC.3 TA-TONG ROAD Shi-chih District, TW 22103 |
Contact | Yen-ming Pan |
Correspondent | Yen-ming Pan Panpac Medical Corporation 6F-1,2, NO. 202, SEC.3 TA-TONG ROAD Shi-chih District, TW 22103 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-25 |
Decision Date | 2016-07-14 |