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510(k) K874668

SPERM WASHING MEDIUM #9983 & MODIFIED #9984 by Irvine Scientific — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
November 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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