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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K851101
Device Name BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET
Applicant
Bionomy, Inc.
P.O. Box 270882
Tampa,  FL  33688
Applicant Contact ELIZABETH M PAUL
Correspondent
Bionomy, Inc.
P.O. Box 270882
Tampa,  FL  33688
Correspondent Contact ELIZABETH M PAUL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/19/1985
Decision Date 04/12/1985
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
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