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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condenser, heat and moisture (artificial nose)
510(k) Number K952845
Device Name HUMID-VENT TRACH-VENT
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 Number868.5375
Classification Product Code
BYD  
Date Received06/21/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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