GENT-L-KARE TRACHEOSTOMY TRAYS— 510(k) K950851

Name: FDA 510(k) clearance K950851
Creator: U.S. Food and Drug Administration
Published: 1995-06-21

Substantially Equivalent

Premium Plastics, Inc.

FDA 510(k) clearance K950851 for GENT-L-KARE TRACHEOSTOMY TRAYS, Substantially Equivalent on 1995-06-21. Applicant: Premium Plastics, Inc.. Device class: 1.

Clearance details

Applicant: Premium Plastics, Inc.
Product code: Code LRQ
Device class: Class 1
Advisory panel: Unknown
Date received: 1995-02-24
Decision date: 1995-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K862663 — TRACHEOSTOMY CARE TRAY1986-07-30

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K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT1989-10-24
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Data sourced from openFDA. This site is unofficial and independent of the FDA.