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510(k) K113043

DIRECT ANTIBIOTIC INFUSION KIT by Summit Medical Products, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2011
Date Received
October 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Summit Medical Products, Inc.

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  • K102460 — AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH (January 13, 2011)

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