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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 K841330
Device Name GASTROSTOMY FEEDING TUBE
Applicant
MICROVASIVE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MICROVASIVE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/02/1984
Decision Date 05/22/1984
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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