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510(k) K894405

HTF WITH ALBUMIN (CATALOG NO. 9994) by Irvine Scientific — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1989
Date Received
July 17, 1989
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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