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510(k) K833061

C-FLEX PENROSE DRAINAGE TUBE by Concept, Inc. — Product Code FFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1983
Date Received
September 9, 1983
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

Other clearances by Concept, Inc.

  • K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE (May 1, 1992)
  • K912957 — CONCEPT MICROMILL (October 4, 1991)
  • K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (June 5, 1990)
  • K894929 — STAPLE FIXATION SYSTEM (August 30, 1989)
  • K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (August 1, 1989)
  • K891109 — PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (May 8, 1989)
  • K881954 — CONCEPT POWER SYSTEM (November 9, 1988)
  • K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (November 8, 1988)
  • K882121 — C-FLO SUCTION TUBE (June 20, 1988)
  • K880414 — TENDON HARVESTER (March 25, 1988)

Other clearances for product code FFA

  • K944290 — CATHETERS, BILIARY CATHETERS, UROLOGICAL (December 8, 1994)
  • K864770 — SUCTION TUBE (February 24, 1987)