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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K161250
Device Name OC-FLEX Flexible IntraOral Cannula
Applicant
Venture Therapeutics, Inc.
6525 Doubletree Avenue
Columbus,  OH  43229
Applicant Contact Marilyn A. Friedly
Correspondent
Venture Therapeutics, Inc.
6525 Doubletree Avenue
Columbus,  OH  43229
Correspondent Contact Marilyn A. Friedly
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/03/2016
Decision Date 03/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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