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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K802914
Device Name 6-435 FILTER PAD, 5/PKG.
Applicant
Lifecare Services, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Lifecare Services, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5260
Classification Product Code
CAH  
Date Received11/18/1980
Decision Date 12/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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