510(k) K910317
K910317 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "UNI-SEM(TM)". The FDA issued a decision of Substantially Equivalent on May 1, 1991. The device falls under product code MFD (Cannula, Intrauterine Insemination), a Class II device regulated under 21 CFR 884.5250. Unimar, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 1991
- Date Received
- January 24, 1991
- 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