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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 K020474
Device Name MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
Applicant
MAKRITE INDUSTRIES, INC.
24 TOWER ST.
WEBSTER,  MA  01570
Applicant Contact JOSEPH Z ZDROK
Correspondent
MAKRITE INDUSTRIES, INC.
24 TOWER ST.
WEBSTER,  MA  01570
Correspondent Contact JOSEPH Z ZDROK
Regulation Number878.4040
Classification Product Code
MSH  
Date Received02/12/2002
Decision Date 07/23/2002
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
Predetermined Change
Control Plan Authorized		 No
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