510(k) K083769
K083769 is an FDA 510(k) premarket notification submitted by Eastmed, Inc. for the device "MODIFICATION TO URESTA PESSARY". The FDA issued a decision of Substantially Equivalent on January 14, 2009. 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
- January 14, 2009
- Date Received
- December 18, 2008
- Clearance Type
- Special
- 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