PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS


Device Classification Name

drape, surgical

510(k) Number K080629
Device Name PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
Applicant
PROMEDICAL PRODUCTS CO., LTD.
# 206 haung he road west
changzhou, jiangsu, 

CN

213022

Applicant Contact leo wei
Correspondent
PROMEDICAL PRODUCTS CO., LTD.
# 206 haung he road west
changzhou, jiangsu, 

CN

213022

Correspodent Contact leo wei
Regulation Number 878.4370
Classification Product Code
KKX  
Subsequent Product Code
MMP  
Date Received 03/05/2008
Decision Date 10/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No