510(k) K070689
K070689 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "LG SPERM FREEZING". The FDA issued a decision of Substantially Equivalent on July 3, 2007. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2007
- Date Received
- March 13, 2007
- 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