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510(k) K120694

ENCORE 26 ADVANTAGE KIT by Boston Scientific Corp — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2012
Date Received
March 7, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

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Other clearances for product code MAV

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  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
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  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
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