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510(k) K010545

TBW by Tri-Med, Inc. — Product Code NDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
February 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth, Metallic
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Tri-Med, Inc.

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  • K961863 — PARACENTESIS TRAYS (May 28, 1996)
  • K875224 — HUDSON CRANINAL BURRS (January 28, 1988)
  • K850746 — TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (April 2, 1985)
  • K850745 — TRI-MED MODEL 112 MOISTURE TRAP (April 2, 1985)
  • K850747 — TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (April 2, 1985)
  • K843681 — RESPIRATION & HEART RATE MONITOR 530 (December 4, 1984)
  • K843285 — TRI-MED 610 CAPNOSTAT GAS ANALYZER (November 13, 1984)
  • K842399 — 48 HOUR SET CHANGES (October 9, 1984)

Other clearances for product code NDL

  • K010847 — K'FIX (June 19, 2001)