GEL-T CUSHION— 510(k) K960189

Name: FDA 510(k) clearance K960189
Creator: U.S. Food and Drug Administration
Published: 1996-02-07

Substantially Equivalent

Span-America Medical Systems, Inc.

FDA 510(k) clearance K960189 for GEL-T CUSHION, Substantially Equivalent on 1996-02-07. Applicant: Span-America Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Span-America Medical Systems, Inc.
Product code: Code KIC
Device class: Class 1
Regulation: 21 CFR 890.3175
Advisory panel: Physical Medicine
Date received: 1996-01-16
Decision date: 1996-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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