510(k) K202542
K202542 is an FDA 510(k) premarket notification submitted by Pmt Corporation for the device "Allura Vaginal Stent". The FDA issued a decision of Substantially Equivalent on September 30, 2020. The device falls under product code KXP (Stent, Vaginal), a Class II device regulated under 21 CFR 884.3900. Pmt Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2020
- Date Received
- September 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stent, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3900
- Review Panel
- OB
- Submission Type