SURGICAL FACE MASK; SURGICAL FACE MASK


Device Classification Name

mask, surgical

510(k) Number K110027
Device Name SURGICAL FACE MASK; SURGICAL FACE MASK
Applicant
ANGELINE GROUP LTD.
no.45, minsheng rd
danshui town
taipei county, 

TW

251

Applicant Contact michael lee
Correspondent
ANGELINE GROUP LTD.
no.45, minsheng rd
danshui town
taipei county, 

TW

251

Correspodent Contact michael lee
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 01/05/2011
Decision Date 08/05/2011
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