510(k) K132313
K132313 is an FDA 510(k) premarket notification submitted by Eis Corporation for the device "PESSARY". The FDA issued a decision of Substantially Equivalent on December 5, 2014. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2014
- Date Received
- July 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type