The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Vaginal Dilators.
| Device ID | K130273 |
| 510k Number | K130273 |
| Device Name: | PANPAC VAGINAL DILATORS |
| Classification | Dilator, Vaginal |
| Applicant | Panpac Medical Corporation 6F-1, 2 NO. 202, SEC 3 TA-TONG ROAD Shi-chih District, New Taipei City, 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, New Taipei City, TW 22103 |
| Product Code | HDX |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-04 |
| Decision Date | 2013-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04715309129418 | K130273 | 000 |
| 00840319733639 | K130273 | 000 |
| 00840319733622 | K130273 | 000 |
| 00840319733615 | K130273 | 000 |
| 04719894432229 | K130273 | 000 |
| 04719894432212 | K130273 | 000 |
| 04719894432205 | K130273 | 000 |
| 04719894432304 | K130273 | 000 |
| 04719894432298 | K130273 | 000 |
| 04719894432281 | K130273 | 000 |
| 04719894432274 | K130273 | 000 |
| 04719894432267 | K130273 | 000 |
| 04719894432250 | K130273 | 000 |
| 04719894432243 | K130273 | 000 |
| 10888277632110 | K130273 | 000 |
| 10888277632127 | K130273 | 000 |
| 04715309129401 | K130273 | 000 |
| 04715309122198 | K130273 | 000 |
| 04715309122181 | K130273 | 000 |
| 04715309122174 | K130273 | 000 |
| 04715309122167 | K130273 | 000 |
| 04715309122150 | K130273 | 000 |
| 04715309122143 | K130273 | 000 |
| 04715309122136 | K130273 | 000 |
| 04715309122129 | K130273 | 000 |
| 04715309122112 | K130273 | 000 |
| 04715309122105 | K130273 | 000 |
| 04715309121474 | K130273 | 000 |
| 10888277632134 | K130273 | 000 |
| 04719894432236 | K130273 | 000 |