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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 K914792
Device Name PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET
Applicant
Filtertek, Inc.
P.O. Box 310 Price Rd.
Hebron,  IL  60034
Applicant Contact LARRY LARKIN
Correspondent
Filtertek, Inc.
P.O. Box 310 Price Rd.
Hebron,  IL  60034
Correspondent Contact LARRY LARKIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/23/1991
Decision Date 01/15/1992
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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