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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, fixation, tracheal tube
510(k) Number K922657
Device Name AGA TRACH TIES
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 Number868.5770
Classification Product Code
CBH  
Date Received06/03/1992
Decision Date 07/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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