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510(k) K971320

CRE BALLOON DILATATION CATHETER by Boston Scientific Corp — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1997
Date Received
April 10, 1997
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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