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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K982894
Device Name MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
Applicant
BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER,  UT  84020
Applicant Contact E. MARTIN CHAMBERLAIN
Correspondent
BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER,  UT  84020
Correspondent Contact E. MARTIN CHAMBERLAIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/17/1998
Decision Date 09/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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