AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C


Device Classification Name

respirator,surgical

510(k) Number K072359
Device Name AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
Applicant
AEARO COMPANY
90 mechanic st.
southbridge, 
MA 
01550

Applicant Contact ann l phillips
Correspondent
AEARO COMPANY
90 mechanic st.
southbridge, 
MA 
01550

Correspodent Contact ann l phillips
Regulation Number 878.4040
Classification Product Code
MSH  
Date Received 08/22/2007
Decision Date 11/08/2007
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