PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A


Device Classification Name

gown, surgical

510(k) Number K080627
Device Name PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
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 878.4040
Classification Product Code
FYA  
Date Received 03/05/2008
Decision Date 04/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No