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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 K912352
Device Name PEACE MODEL 100 CUFF MONITOR
Applicant
Peace Medical, Inc.
50 S.Center St.
Suite 11
Orange,  NJ  07050
Applicant Contact KEVIN FEGAN
Correspondent
Peace Medical, Inc.
50 S.Center St.
Suite 11
Orange,  NJ  07050
Correspondent Contact KEVIN FEGAN
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/28/1991
Decision Date 08/02/1991
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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