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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K760481
Device Name FILTER, PARTICULATE ARRESTING
Applicant
Miles Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Miles Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5045
Classification Product Code
FRF  
Date Received08/17/1976
Decision Date 09/15/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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