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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, fistula
510(k) Number K770699
Device Name NEEDLE SET, A-V FISTULA
Applicant
MEDICAL DISPOSABLES INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICAL DISPOSABLES INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5540
Classification Product Code
FIE  
Date Received04/18/1977
Decision Date 06/14/1977
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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