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510(k) K061787

MAXFORCE TTS SINGLE-USE BALLOON DILATOR by Boston Scientific Corp — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2006
Date Received
June 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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