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510(k) K823913

SOFT GRIP UNI-HANDLE by Treace Medical, Inc. — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
December 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Treace Medical, Inc.

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  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)

Other clearances for product code EJB

  • K140144 — BENDA WEDGE (July 8, 2014)
  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)
  • K981234 — FLARE,FILE, FILL (June 5, 1998)
  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)