K130273 is an FDA 510(k) clearance for the PANPAC VAGINAL DILATORS. This device is classified as a Dilator, Vaginal (Class II - Special Controls, product code HDX).
Submitted by Panpac Medical Corporation (Shi-Chib District, Taipei Hsien, TW). The FDA issued a Cleared decision on August 8, 2013, 185 days after receiving the submission on February 4, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K130273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2013 |
| Decision Date | August 08, 2013 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDX — Dilator, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |