H.P. MEDICAL GRADE SILICONE TUBING— 510(k) K780470

Name: FDA 510(k) clearance K780470
Creator: U.S. Food and Drug Administration
Published: 1978-04-27

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K780470 for H.P. MEDICAL GRADE SILICONE TUBING, Substantially Equivalent on 1978-04-27. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1978-03-22
Decision date: 1978-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.