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510(k) K982098

TUTODROP 1 AND TUTODROP 2 by Myco Medical Supplies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1999
Date Received
June 15, 1998
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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