510(k) K080395
K080395 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "SUNIVF DISHES". The FDA issued a decision of Substantially Equivalent on August 13, 2008. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2008
- Date Received
- February 13, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type