510(k) K021193
K021193 is an FDA 510(k) premarket notification submitted by Fortune Medical Instrument Corp. for the device "FORTUNE SILICONE VACUUM SUCTION, MODEL #1300". The FDA issued a decision of Substantially Equivalent on February 12, 2003. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Fortune Medical Instrument Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2003
- Date Received
- April 15, 2002
- 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