The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Flexi Shelf Pessary.
| Device ID | K173351 |
| 510k Number | K173351 |
| Device Name: | Panpac Flexi Shelf Pessary |
| Classification | Pessary, Vaginal |
| Applicant | Panpac Medical Corporation 6F-1,-2, No. 202, Sec. 3, Ta-Tong Rd. Shi-chih Dist., TW 22103 |
| Contact | Yen-ming Pan |
| Correspondent | Yen-ming Pan Panpac Medical Corporation 6F-1,-2, No. 202, Sec. 3, Ta-Tong Rd. Shi-chih Dist., TW 22103 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-25 |
| Decision Date | 2018-10-31 |