UNIVERSAL DRAINAGE TRAY— 510(k) K961442

Substantially Equivalent

Customed, Inc.

FDA 510(k) clearance K961442 for UNIVERSAL DRAINAGE TRAY, Substantially Equivalent on 1996-05-09. Applicant: Customed, Inc.. Device class: 2.

Clearance details

Applicant: Customed, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-15
Decision date: 1996-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fajardo, PR, US

Download summary PDF View on FDA.gov ↗

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