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510(k) K033589

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR by Micromedics, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2004
Date Received
November 13, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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