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510(k) K944290

CATHETERS, BILIARY CATHETERS, UROLOGICAL by Boston Scientific Corp — Product Code FFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Drainage, Suprapubic
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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Other clearances for product code FFA

  • K864770 — SUCTION TUBE (February 24, 1987)
  • K833061 — C-FLEX PENROSE DRAINAGE TUBE (November 7, 1983)