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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 K062663
Device Name MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
Applicant
MOLDEX/METRIC, INC.
10111 WEST JEFFERSON BLVD.
CULVER CITY,  CA  90232
Applicant Contact WILLIAM WAWRZYNIAK
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number878.4040
Classification Product Code
MSH  
Date Received09/07/2006
Decision Date 10/11/2006
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
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