510(k) K031304
K031304 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "SYDNEY IVF PVP". The FDA issued a decision of Substantially Equivalent on March 23, 2004. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2004
- Date Received
- April 24, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type