510(k) K043614
K043614 is an FDA 510(k) premarket notification submitted by Medevco, Inc. for the device "VACULINK, MODEL VCL 3000". The FDA issued a decision of Substantially Equivalent on April 14, 2005. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2005
- Date Received
- December 30, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractor, Vacuum, Fetal
- Device Class
- Class II
- Regulation Number
- 884.4340
- Review Panel
- OB
- Submission Type