ZERO-G(TM) GEL/FOAM MATTRESS TOPPER— 510(k) K911843

Name: FDA 510(k) clearance K911843
Creator: U.S. Food and Drug Administration
Published: 1991-05-30

Substantially Equivalent

Steridyne Corp.

FDA 510(k) clearance K911843 for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER, Substantially Equivalent on 1991-05-30. Applicant: Steridyne Corp.. Device class: 1.

Clearance details

Applicant: Steridyne Corp.
Product code: Code KIC
Device class: Class 1
Regulation: 21 CFR 890.3175
Advisory panel: Physical Medicine
Date received: 1991-04-25
Decision date: 1991-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riviera Beach, FL, 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.