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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbent, Carbon-Dioxide
510(k) Number K897171
Device Name DISPOSABLE CO2 ABSORBER/E
Applicant
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Applicant Contact PAUL E DRYDEN
Correspondent
Gibeck, Inc.
10640 E. 59th St.
P.O. Box 36430
Indianapolis,  IN  46236
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5300
Classification Product Code
CBL  
Date Received12/28/1989
Decision Date 03/13/1990
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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