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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K875073
Device Name BREATHE-FREE
Applicant
Cincinnati Medical Technologies, Inc.
11272 Sebring Dr.
Cincinnati,  OH  45240
Applicant Contact ROBERT W MARKI
Correspondent
Cincinnati Medical Technologies, Inc.
11272 Sebring Dr.
Cincinnati,  OH  45240
Correspondent Contact ROBERT W MARKI
Regulation Number868.5965
Classification Product Code
BYE  
Date Received12/09/1987
Decision Date 02/29/1988
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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