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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
510(k) Number K781749
Device Name TUBING, AXIOM SILICONE PENROSE
Applicant
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5980
Classification Product Code
KDH  
Date Received10/17/1978
Decision Date 12/04/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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