HYDRO-SPLINT A SPONGE-COMPRESS DRESS— 510(k) K843400

Name: FDA 510(k) clearance K843400
Creator: U.S. Food and Drug Administration
Published: 1984-10-24

Substantially Equivalent

Compression Splint Products, Inc.

FDA 510(k) clearance K843400 for HYDRO-SPLINT A SPONGE-COMPRESS DRESS, Substantially Equivalent on 1984-10-24. Applicant: Compression Splint Products, Inc.. Device class: 1.

Clearance details

Applicant: Compression Splint Products, Inc.
Product code: Code FYH
Device class: Class 1
Regulation: 21 CFR 878.3910
Advisory panel: General, Plastic Surgery
Date received: 1984-08-30
Decision date: 1984-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, P, US

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