HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810


Device Classification Name

respirator,surgical

510(k) Number K080827
Device Name HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
Applicant
HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L
1-1-1201, 455 gongnong road
shijiazhuang, hebei province, 

CN

050051

Applicant Contact maggie zhong
Correspondent
HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L
1-1-1201, 455 gongnong road
shijiazhuang, hebei province, 

CN

050051

Correspodent Contact maggie zhong
Regulation Number 878.4040
Classification Product Code
MSH  
Date Received 03/25/2008
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No