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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K923800
Device Name PRESSURE GAUGE
Applicant
Innovations For Mechanical Ventilation, Inc.
8 Amherst Rd.
New City,  NY  10956
Applicant Contact RALPH A MILLIKEN
Correspondent
Innovations For Mechanical Ventilation, Inc.
8 Amherst Rd.
New City,  NY  10956
Correspondent Contact RALPH A MILLIKEN
Regulation Number868.5750
Classification Product Code
BSK  
Date Received07/29/1992
Decision Date 02/26/1993
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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