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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 K896832
Device Name FILT-R-ALL BACTERIAL FILTER
Applicant
INHALATION PLASTICS
7790 N. MERRIMAC
CHICAGO,  IL  60648
Applicant Contact JAMES LEKKAS
Correspondent
INHALATION PLASTICS
7790 N. MERRIMAC
CHICAGO,  IL  60648
Correspondent Contact JAMES LEKKAS
Regulation Number868.5260
Classification Product Code
CAH  
Date Received12/05/1989
Decision Date 01/22/1990
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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