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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 K012958
Device Name BREATHING CIRCUIT FILTER
Applicant
Emergency Filtration Products, Inc.
4335 S. Industrial Rd.,#440
Las Vegas,  NV  89103
Applicant Contact DOUGLAS K BEPLATE
Correspondent
Emergency Filtration Products, Inc.
4335 S. Industrial Rd.,#440
Las Vegas,  NV  89103
Correspondent Contact DOUGLAS K BEPLATE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/04/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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