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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K070168
Device Name N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
Applicant
Aearo Company
90 Mechanic St.
Southbridge,  MA  01550
Applicant Contact ANN L PHILLIPS
Correspondent
Aearo Company
90 Mechanic St.
Southbridge,  MA  01550
Correspondent Contact ANN L PHILLIPS
Regulation Number878.4040
Classification Product Code
MSH  
Date Received01/18/2007
Decision Date 04/18/2007
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
Predetermined Change
Control Plan Authorized		 No
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