DERMABIOSAFE


Device Classification Name

electrode, cutaneous

510(k) Number K080298
Device Name DERMABIOSAFE
Applicant
COMPLETE PRODUCT RESOURCES
92 argonaut # 200
aliso viejo, 
CA 
92656

Applicant Contact john walsh
Correspondent
COMPLETE PRODUCT RESOURCES
92 argonaut # 200
aliso viejo, 
CA 
92656

Correspodent Contact john walsh
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 02/05/2008
Decision Date 08/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No