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510(k) K000592

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET by Myco Medical Supplies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2001
Date Received
February 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K963364 — GLASS VAN GLASS SYRINGES (May 1, 1998)
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