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510(k) K862523

MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS by Walter Lorenz Surgical, Inc. — Product Code EKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Broach, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITAN (June 6, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (May 14, 2004)
  • K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (May 13, 2004)
  • K040983 — LORENZ SELF-DRILLING IMF SCREW (May 5, 2004)
  • K033740 — LORENZ STERNAL CLOSURE SYSTEM (December 15, 2003)

Other clearances for product code EKW

  • K871493 — DENTI-TRAY(TM) (June 24, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACH (July 12, 1983)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)
  • K800292 — ENDEX BROACH, ENDODONTIC (February 19, 1980)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)