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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K781333
Device Name CENTRAL CATHETER TRAY
Applicant
ARGON MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ARGON MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5980
Classification Product Code
KGC  
Date Received08/02/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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