510(k) K993308
K993308 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR EVACARE VAGINAL PESSARIES". The FDA issued a decision of Substantially Equivalent on December 13, 1999. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Mentor Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1999
- Date Received
- October 4, 1999
- 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