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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 K901263
Device Name NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM
Applicant
Navion Biomedical Corp.
27 Maple Ave.
P.O. Box 365
Holbrook,  MA  02343
Applicant Contact DONALD A KAY
Correspondent
Navion Biomedical Corp.
27 Maple Ave.
P.O. Box 365
Holbrook,  MA  02343
Correspondent Contact DONALD A KAY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/16/1990
Decision Date 08/22/1990
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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