510(k) K972245

TOM CAT F.L., TOM CAT S.L. by A & A Medical, Inc. — Product Code MFD

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