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510(k) K914792

PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET by Filtertek, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1992
Date Received
October 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Filtertek, Inc.

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  • K912848 — I.V. FILTER EXTENSION SET (November 29, 1991)
  • K912394 — TRANSDUCER PROTECTOR (August 30, 1991)
  • K911451 — I.V. EXTENDER SET (June 6, 1991)
  • K904912 — TRANSDUCER PROTECTOR (January 4, 1991)
  • K901409 — TRANSDUCER PROTECTOR (July 27, 1990)
  • K901996 — FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR (June 1, 1990)
  • K895281 — TRANSDUCER PROTECTOR (November 8, 1989)

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