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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 K063013
Device Name PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
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 Received10/02/2006
Decision Date 12/01/2006
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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