The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Word/bartholin Catheter.
| Device ID | K130087 |
| 510k Number | K130087 |
| Device Name: | PANPAC WORD/BARTHOLIN CATHETER |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| 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 | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2014-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309121986 | K130087 | 000 |
| GYNX102001 | K130087 | 000 |
| 04719894432557 | K130087 | 000 |