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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 K062665
Device Name INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
Applicant
Inovel, LLC
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact WILLIAM WAWRZYNIAK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4040
Classification Product Code
MSH  
Date Received09/07/2006
Decision Date 10/24/2006
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
Predetermined Change
Control Plan Authorized		 No
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