510(k) K993953
K993953 is an FDA 510(k) premarket notification submitted by Veos , Ltd. for the device "OVES CERVICAL CAP". The FDA issued a decision of SESU on March 21, 2000. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250.
Clearance Details
- Decision
- SESU ()
- Decision Date
- March 21, 2000
- Date Received
- November 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type