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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K892438
Device Name KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact WILLIAM D CURTIN
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact WILLIAM D CURTIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/1989
Decision Date 07/24/1989
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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