O&P CRANICAL MOLDING HELMET


Device Classification Name

orthosis, cranial

510(k) Number K021221
Device Name O&P CRANICAL MOLDING HELMET
Original Applicant
ORTHOTIC & PROSTHETIC LAB, INC.
748 marshall ave.
webster groves, 
MO 
63119

Original Contact thomas malone
Regulation Number 882.5970
Classification Product Code
MVA  
Date Received 04/17/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No