SOF. CARE CUSHION & SOF-CARE CUSHION COVER— 510(k) K851027

Name: FDA 510(k) clearance K851027
Creator: U.S. Food and Drug Administration
Published: 1985-06-18

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K851027 for SOF. CARE CUSHION & SOF-CARE CUSHION COVER, Substantially Equivalent on 1985-06-18. Applicant: Gaymar Industries, Inc.. Device class: 1.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code KIC
Device class: Class 1
Regulation: 21 CFR 890.3175
Advisory panel: Physical Medicine
Date received: 1985-03-12
Decision date: 1985-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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