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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K101439
Device Name CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
Applicant
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Applicant Contact GARY W ENOS
Correspondent
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Correspondent Contact GARY W ENOS
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received05/24/2010
Decision Date 02/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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