GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS


Device Classification Name

drape, surgical

510(k) Number K111458
Device Name GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
Applicant
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
717 lakeglen drive
suwanee, 
GA 
30024

Applicant Contact penny northcutt
Correspondent
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
717 lakeglen drive
suwanee, 
GA 
30024

Correspodent Contact penny northcutt
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 05/26/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No