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 |