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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, aspirating, flexible, connecting
510(k) Number K960616
Device Name VITAFLOW SUCTION/ASPIRATION TUBING SET
Applicant
VITAL CONCEPTS, INC.
5090 KENDRICK COURT S.E.
GRAND RAPIDS,  MI  49512
Applicant Contact S. NICHOLAS AYOUB
Correspondent
VITAL CONCEPTS, INC.
5090 KENDRICK COURT S.E.
GRAND RAPIDS,  MI  49512
Correspondent Contact S. NICHOLAS AYOUB
Regulation Number880.6740
Classification Product Code
BYY  
Date Received02/13/1996
Decision Date 05/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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