The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Inflatable Docut Pessary.
| Device ID | K132670 |
| 510k Number | K132670 |
| Device Name: | PANPAC INFLATABLE DOCUT 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 | 2013-08-27 |
| Decision Date | 2014-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309122280 | K132670 | 000 |
| 04715309122273 | K132670 | 000 |
| 04715309122266 | K132670 | 000 |
| 04715309122259 | K132670 | 000 |