510(k) K963031
K963031 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "GENXCATHETER". The FDA issued a decision of Substantially Equivalent on October 21, 1996. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1996
- Date Received
- August 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Intrauterine Insemination
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type