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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 K924660
Device Name TRACHEOSTOMY TUBE AND TUBE CUFF
Applicant
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number868.5800
Classification Product Code
JOH  
Date Received09/15/1992
Decision Date 12/11/1992
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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