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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 K953491
Device Name HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
Applicant
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Applicant Contact BRIAN GRIGSBY
Correspondent
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Correspondent Contact BRIAN GRIGSBY
Regulation Number868.5375
Classification Product Code
BYD  
Date Received07/25/1995
Decision Date 08/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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