THERA-CREAM, MODEL TCT004— 510(k) K032239

Substantially Equivalent

Prizm Medical, Inc.

FDA 510(k) clearance K032239 for THERA-CREAM, MODEL TCT004, Substantially Equivalent on 2004-07-30. Applicant: Prizm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Prizm Medical, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2003-07-21
Decision date: 2004-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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