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510(k) K822349

ARMSTRONG V TUBE SUCTION INSERTER by Treace Medical, Inc. — Product Code JYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1982
Date Received
August 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Inserter, Myringotomy Tube
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)
  • K870760 — BUR BRUSH (March 18, 1987)

Other clearances for product code JYM

  • K924901 — DEANS DISPOSABLE T-TUBE INSERTER (January 28, 1993)
  • K870978 — T-TUBE INSERTER (March 19, 1987)
  • K822348 — TYTAN TUBE INSERTER (September 7, 1982)