SMARTSPONGE PLUS SYSTEM


Device Classification Name

counter, sponge, surgical

510(k) Number K073180
Device Name SMARTSPONGE PLUS SYSTEM
Applicant
CLEARCOUNT MEDICAL SOLUTIONS, INC.
101 bellevue road
suite 300
pittsburgh, 
PA 
15229

Applicant Contact jeff wolfgong
Regulation Number 880.2740
Classification Product Code
LWH  
Date Received 11/13/2007
Decision Date 11/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No