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510(k) K811378

PERCUTANEOUS DRAINING CATHETER by Medi-Tech, Inc. — Product Code GBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
May 15, 1981
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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  • K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS (June 1, 1995)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)

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  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (March 21, 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)