CLARREN HELMET (ORTHOMERICA)


Device Classification Name

orthosis, cranial, laser scan

510(k) Number K021918
Device Name CLARREN HELMET (ORTHOMERICA)
Original Applicant
ORTHOMERICA PRODUCTS, INC.
6333 north orange blossom
trail
orlando, 
FL 
32810

Original Contact deanna fish
Regulation Number 882.5970
Classification Product Code
OAN  
Date Received 06/11/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No