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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, flexible
510(k) Number K895080
Device Name SURGICAL GLOVES
Applicant
JET FAR INDUSTRIES, INC.
COMPREG ADMINISTRATION, INC.
P.O. BOX 3119
SEAL BEACH,  CA  90740
Applicant Contact JAMES E LENICK
Correspondent
JET FAR INDUSTRIES, INC.
COMPREG ADMINISTRATION, INC.
P.O. BOX 3119
SEAL BEACH,  CA  90740
Correspondent Contact JAMES E LENICK
Regulation Number876.4680
Classification Product Code
FGO  
Date Received08/14/1989
Decision Date 01/24/1990
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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