COOL CAST(R)— 510(k) K903946

Substantially Equivalent

Hawthorne Products, Inc.

FDA 510(k) clearance K903946 for COOL CAST(R), Substantially Equivalent on 1990-12-31. Applicant: Hawthorne Products, Inc.. Device class: 1.

Clearance details

Applicant: Hawthorne Products, Inc.
Product code: Code LGF
Device class: Class 1
Regulation: 21 CFR 888.5940
Advisory panel: Orthopedic
Date received: 1990-08-27
Decision date: 1990-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunkirk, IN, US

Download summary PDF View on FDA.gov ↗

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