510(k) K130273
K130273 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC VAGINAL DILATORS". The FDA issued a decision of Substantially Equivalent on August 8, 2013. The device falls under product code HDX (Dilator, Vaginal), a Class II device regulated under 21 CFR 884.3900. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2013
- Date Received
- February 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3900
- Review Panel
- OB
- Submission Type