SICAT IMPLANT V1.2


Device Classification Name

system, image processing, radiological

510(k) Number K103723
Device Name SICAT IMPLANT V1.2
Applicant
SICAT GMBH & CO. KG
49 plain street
north attleboro, 
MA 
02760

Applicant Contact mark w sheehan
Correspondent
SICAT GMBH & CO. KG
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact mark w sheehan
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/21/2010
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No