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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 K954828
Device Name ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
Original Applicant
GIBECK, INC.
10640 east 59th st.
p.o. box 36430
indianapolis,  IN  46236
Original Contact brian grigsby
Regulation Number868.5260
Classification Product Code
CAH  
Date Received10/20/1995
Decision Date 05/02/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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