SHENGKUN CHEMICAL


Device Classification Name

vinyl patient examination glove

510(k) Number K110621
Device Name SHENGKUN CHEMICAL
Applicant
ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD
fine chemical park, chemical
industry park zibo, shandong
zibo, shandong, 

CN

255400

Applicant Contact jason liu
Correspondent
ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD
fine chemical park, chemical
industry park zibo, shandong
zibo, shandong, 

CN

255400

Correspodent Contact jason liu
Regulation Number 880.6250
Classification Product Code
LYZ  
Date Received 03/03/2011
Decision Date 08/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No