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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 K911443
Device Name INSUL-LINE
Applicant
Trademark Corp.
1053 Headquarters Park
Fenton,  MO  63026
Applicant Contact HARRY O TIGGARD
Correspondent
Trademark Corp.
1053 Headquarters Park
Fenton,  MO  63026
Correspondent Contact HARRY O TIGGARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/01/1991
Decision Date 07/26/1991
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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