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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K925438
Device Name COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT
Applicant
Aga Medical Products, Inc.
903 Dolphin Dr.
Malvern,  PA  19355
Applicant Contact MICHAEL SCHUSTER
Correspondent
Aga Medical Products, Inc.
903 Dolphin Dr.
Malvern,  PA  19355
Correspondent Contact MICHAEL SCHUSTER
Regulation Number868.5800
Classification Product Code
JOH  
Date Received10/28/1992
Decision Date 02/17/1993
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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