CUTTER RESIFLEX FOLEY CATHETERS— 510(k) K781140

Name: FDA 510(k) clearance K781140
Creator: U.S. Food and Drug Administration
Published: 1978-09-07

Substantially Equivalent

Cutler Laboratories, Inc.

FDA 510(k) clearance K781140 for CUTTER RESIFLEX FOLEY CATHETERS, Substantially Equivalent on 1978-09-07. Applicant: Cutler Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cutler Laboratories, Inc.
Product code: Code DJC
Device class: Class 2
Regulation: 21 CFR 862.3610
Advisory panel: Clinical Toxicology
Date received: 1978-08-21
Decision date: 1978-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

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