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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Declotting Tray, Kit (Including Contents)
510(k) Number K821666
Device Name STERILE SURGICAL DRAPES
Applicant
PHOENIX GLOVE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHOENIX GLOVE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FJZ  
Date Received06/07/1982
Decision Date 06/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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