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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
FOIA Releasable 510(k) K954828
Device Name ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
Applicant
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS,  IN  46236
Applicant Contact BRIAN GRIGSBY
Correspondent
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS,  IN  46236
Correspondent 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 General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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