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510(k) K914541

SPERM MAINTENANCE MEDIUM WITH GLYCEROL by Irvine Scientific — Product Code MFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
October 11, 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

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  • K972245 — TOM CAT F.L., TOM CAT S.L. (August 6, 1997)
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