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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 K931217
Device Name BREATHING FILTER
Applicant
Teknor Medical Products, Inc.
P.O. Box 22017
Trenton, Ontario,  CA K8V 6S3
Applicant Contact PETER F HUFF
Correspondent
Teknor Medical Products, Inc.
P.O. Box 22017
Trenton, Ontario,  CA K8V 6S3
Correspondent Contact PETER F HUFF
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/10/1993
Decision Date 04/23/1993
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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