510(k) K974563
K974563 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "COLPO CUP CVC-2000". The FDA issued a decision of Substantially Equivalent on Mar 2, 1998. The device falls under product code HDP (Elevator, Uterine), a Class II device regulated under 21 CFR 884.4530. Clinical Innovations, Inc. has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 1998
- Date Received
- Dec 5, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Elevator, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k)