510(k) K972245
K972245 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "TOM CAT F.L., TOM CAT S.L.". The FDA issued a decision of Substantially Equivalent on August 6, 1997. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1997
- Date Received
- June 16, 1997
- 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