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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K811990
Device Name TRACH CLEANING TRAY
Applicant
Associated Medical Products Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Associated Medical Products Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5300
Classification Product Code
FRL  
Date Received07/13/1981
Decision Date 07/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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