Wilson-Cook Achalasia Balloon— 510(k) K182895
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K182895 for Wilson-Cook Achalasia Balloon, Substantially Equivalent on 2019-01-25. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code PID
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winston-Salem, NC, US
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