510(k) K994327
K994327 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "EMBRYON TRANSFER CATHETERS/SETS". The FDA issued a decision of Substantially Equivalent on February 28, 2000. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Rocket Medical Plc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2000
- Date Received
- December 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type