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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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