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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 K041855
Device Name PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
Applicant
Aearo Co.
90 Mechanic St.
Southbridge,  MA  01550
Applicant Contact ANN PHILLIPS
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact BAHRAM BARZIDEH
Regulation Number878.4040
Classification Product Code
MSH  
Date Received07/09/2004
Decision Date 11/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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