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510(k) K841357

MICRO FLUID APPLICATOR by Treace Medical, Inc. — Product Code JZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1984
Date Received
April 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Ear Suction
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 JZF

  • K973587 — EXMOOR TYMPANOCENTESIS KIT (TK/1) (January 23, 1998)
  • K862903 — MIDDLE EAR VIEWER AND FLUID COLLECTOR (November 24, 1986)
  • K853589 — SHAH SELF-CLEARING MASTOID SUCTION TUBE (December 23, 1985)
  • K822010 — RIGID SUCTION TIPS & RELATED ITEMS (August 12, 1982)