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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 K911080
Device Name HYGIENA-TRACH
Applicant
Apdyne Medical Co.
955 W. Idaho Ave.
Saint Paul,  MN  55117
Applicant Contact MICHAEL W WALSH
Correspondent
Apdyne Medical Co.
955 W. Idaho Ave.
Saint Paul,  MN  55117
Correspondent Contact MICHAEL W WALSH
Regulation Number868.5800
Classification Product Code
JOH  
Date Received03/11/1991
Decision Date 05/20/1991
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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