PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS— 510(k) K012804

Name: FDA 510(k) clearance K012804
Creator: U.S. Food and Drug Administration
Published: 2002-01-17

Substantially Equivalent

Scott E Allen CP

FDA 510(k) clearance K012804 for PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS, Substantially Equivalent on 2002-01-17. Applicant: Scott E Allen CP. Device class: 2.

Clearance details

Applicant: Scott E Allen CP
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-08-21
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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