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510(k) K973497

HUBERLOC by Medcare Medical Group, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1998
Date Received
September 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Medcare Medical Group, Inc.

  • K970152 — BIOPSY TRAY (March 5, 1997)
  • K962849 — CATHETER INSERTION TRAY (October 7, 1996)
  • K961075 — MEDCARE REGIONAL ANETHESIA KIT (September 6, 1996)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K962527 — GENERAL PURPOSE DENTAL TRAY (August 1, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)

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