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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K934382
Device Name VCI SUCTION/IRRIGATION TUBING SET
Applicant
Vital Concepts, Inc.
4315 Airwest Dr. SE
Grand Rapids,  MI  49512
Applicant Contact S. NICHOLAS AYOUB
Correspondent
Vital Concepts, Inc.
4315 Airwest Dr. SE
Grand Rapids,  MI  49512
Correspondent Contact S. NICHOLAS AYOUB
Regulation Number880.6740
Classification Product Code
JOL  
Date Received09/09/1993
Decision Date 02/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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