510(k) K993884
K993884 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "GENX MICROTOOLS". The FDA issued a decision of Substantially Equivalent on February 14, 2000. The device falls under product code MQJ (Micromanipulators And Microinjectors, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6150. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2000
- Date Received
- November 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micromanipulators And Microinjectors, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6150
- Review Panel
- OB
- Submission Type