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510(k) K974431

CHEMO-SPIKE II RECONSTITUTION DEVICE by Medi-Dose, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1998
Date Received
November 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K942532 — 2 MICRON AIR ELIMINATING FILTER (August 17, 1994)

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