510(k) K020447
K020447 is an FDA 510(k) premarket notification submitted by Prism Enterprises, Inc. for the device "MITYVAC MERLIN, MODEL 10027". The FDA issued a decision of Substantially Equivalent on April 12, 2002. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Prism Enterprises, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2002
- Date Received
- February 11, 2002
- Clearance Type
- Special
- 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