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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gown, Examination
510(k) Number K811915
Device Name MONITOR/VITAL SIGNS TRAY
Applicant
American Hospital Supply Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Hospital Supply Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6265
Classification Product Code
FME  
Date Received07/01/1981
Decision Date 07/28/1981
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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