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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 K934475
Device Name KOKO FILTER II
Applicant
Pulmonary Data Services Inst., Inc.
P.O. Box 400
Louisville,  CO  80027
Applicant Contact FRED GOOD
Correspondent
Pulmonary Data Services Inst., Inc.
P.O. Box 400
Louisville,  CO  80027
Correspondent Contact FRED GOOD
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/14/1993
Decision Date 10/21/1993
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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