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510(k) K870758

SMALL MASTOID RETRACTOR by Treace Medical, Inc. — Product Code KAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • 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 KAL

  • K833604 — ADJUSTABLE FORK RETRACTOR (January 3, 1984)
  • K772392 — ALLPORT MASTOID RETRACTORS (January 17, 1978)
  • K772381 — RING HANDLE & RETRACTORS (January 17, 1978)
  • K760851 — CONVERSE ALTAR RETRACTOR (March 10, 1977)