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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 K760954
Device Name CROWNTEX EXAM. CAPE & GOWN
Applicant
Graham Manufacturing Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Graham Manufacturing Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6265
Classification Product Code
FME  
Date Received11/02/1976
Decision Date 12/30/1976
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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