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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 K896573
Device Name EASI-LAV ADULT GASTRIC LAVAGE KIT
Applicant
CLAIRSON INDUSTRIES, LLC.
2811 N.E. 14TH ST.
OCALA,  FL  34470
Applicant Contact PHILIP K EFFINGER
Correspondent
CLAIRSON INDUSTRIES, LLC.
2811 N.E. 14TH ST.
OCALA,  FL  34470
Correspondent Contact PHILIP K EFFINGER
Regulation Number876.5980
Classification Product Code
KDH  
Date Received11/20/1989
Decision Date 01/29/1990
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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