CAMLAB CRANIAL ORTHOSIS HELMET— 510(k) K081787

Substantially Equivalent

Biosculptor Corporation

FDA 510(k) clearance K081787 for CAMLAB CRANIAL ORTHOSIS HELMET, Substantially Equivalent on 2009-01-27. Applicant: Biosculptor Corporation.

Clearance details

Applicant
Biosculptor Corporation
Product code
Code OAN
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hialeah, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.