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510(k) K911251

FLEX-IV by Medway — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1991
Date Received
March 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Medway

  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)
  • K911079 — AMB-ALERT (September 13, 1991)
  • K910880 — COMFOR-BOARD (June 6, 1991)

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