SOPRO 281


Device Classification Name

led light source

510(k) Number K103813
Device Name SOPRO 281
Applicant
SOPRO
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Applicant Contact rick rosati
Correspondent
SOPRO
124 gaither drive
suite 140
mt. laurel, 
NJ 
08054

Correspodent Contact rick rosati
Regulation Number 876.1500
Classification Product Code
NTN  
Subsequent Product Code
FCW  
Date Received 12/29/2010
Decision Date 03/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No