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510(k) K050232

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR by Boston Scientific Corp — Product Code PID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2005
Date Received
February 1, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To dilate the lower esophageal sphincter of patients with Achalasia.

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