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510(k) K182895

Device
Wilson-Cook Achalasia Balloon
Applicant
Wilson-Cook Medical, Inc
510(k) number
K182895
Product code
PID  
Decision
Substantially Equivalent (SESE)
Decision date
2019-01-25
Date received
2018-10-15
Regulation
876.5980
Classification name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Theresa de Prat
Address
4900 Bethania Station Rd. Winston-Salem NC US 27105 27105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132337ESOFLIP BALLOON DILATION CATHETERCrospon, Ltd.2013-10-07
K050232RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATORBoston Scientific Corp2005-03-11

Legacy Summary#

summary

FDA Review#

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