The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Vaginal Pessary.
| Device ID | K092981 |
| 510k Number | K092981 |
| Device Name: | PANPAC VAGINAL PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Contact | Yen-ming Pan |
| Correspondent | Yen-ming Pan Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-07-22 |