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510(k) K960426

MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER by Medical Components, Inc. — Product Code GBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1996
Date Received
January 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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Other clearances for product code GBW

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  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K933510 — ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER (February 24, 1994)
  • K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (November 12, 1993)
  • K913733 — STERILE CHEST TUBE (October 8, 1991)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)
  • K894119 — MADEGOM LTDA. PENROSE DRAIN TUBING (August 18, 1989)