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510(k) K823911

KNIFE BLADE TIP by Treace Medical, Inc. — Product Code JYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1983
Date Received
December 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ear
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
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 JYO

  • K910212 — COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (July 11, 1991)
  • K841006 — EAR KNIFE-VARIOUS (May 30, 1984)
  • K840764 — EAR KNIVES (May 21, 1984)
  • K833602 — ROLLER KNIFE-TRANSVERSE -SAGITTAL (January 3, 1984)
  • K772372 — ROLLER KNIFE (January 17, 1978)
  • K772384 — MYRINGOTOMY KNIFE (January 17, 1978)