510(k) K020560
K020560 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "WORKBENCH BY <GENX>". The FDA issued a decision of Substantially Equivalent on June 19, 2002. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2002
- Date Received
- February 20, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type