TOTAL CONTAINMENT DEVICE— 510(k) K913515

Substantially Equivalent

Denco

FDA 510(k) clearance K913515 for TOTAL CONTAINMENT DEVICE, Substantially Equivalent on 1994-05-26. Applicant: Denco. Device class: 2.

Clearance details

Applicant: Denco
Product code: Code KPF
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-07
Decision date: 1994-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.