510(k) K081385
K081385 is an FDA 510(k) premarket notification submitted by Eastmed, Inc. for the device "URESTA PESSARY". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Eastmed, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2008
- Date Received
- May 16, 2008
- 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