LOW PRESSURE TAMPONADE BALLOON CATHETER— 510(k) K941012

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K941012 for LOW PRESSURE TAMPONADE BALLOON CATHETER, Substantially Equivalent on 1994-04-18. Applicant: Applied Medical Resources.

Clearance details

Applicant: Applied Medical Resources
Product code: Code EYB
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-03
Decision date: 1994-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

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