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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 K934272
Device Name SENSORMEDICS MICROGARD MICROBIAL FILTER
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact DAVID M TRUEBLOOD
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact DAVID M TRUEBLOOD
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/31/1993
Decision Date 11/24/1993
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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