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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 K842076
Device Name MIC GASTROSTOMY TUBE
Applicant
MEDICAL INNOVATIONS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Applicant Contact _ _
Correspondent
MEDICAL INNOVATIONS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent Contact _ _
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/23/1984
Decision Date 08/14/1984
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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