SUN-LITE BLUE SLIT— 510(k) K840492

Name: FDA 510(k) clearance K840492
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K840492 for SUN-LITE BLUE SLIT, Substantially Equivalent on 1984-05-09. Applicant: Suncoast Medical Manufacturers, Inc.. Device class: 1.

Clearance details

Applicant: Suncoast Medical Manufacturers, Inc.
Product code: Code HTP
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1984-02-06
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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