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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 K063747
Device Name INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
Applicant
INOVEL LLC
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3509
Applicant Contact WILLIAM WARZYNIAK
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4040
Classification Product Code
MSH  
Date Received12/19/2006
Decision Date 01/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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