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510(k) K954912

TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) by Trebay Medical Corp. — Product Code EQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
October 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type

Other clearances by Trebay Medical Corp.

  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVE (December 22, 1995)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K955447 — TYMPANOSTOMY TUBE (December 21, 1995)
  • K954795 — AT2 & DOYLE STYLE (C-FLEX) VENT TUBES (November 15, 1995)
  • K954796 — MICRO-INGRESSOR HANDIPIECE (November 6, 1995)
  • K954715 — MICRO-PLANER HANDPIECE (October 27, 1995)
  • K954518 — TREBAY TOTAL RECTANGULAR HEAD (October 27, 1995)
  • K954517 — TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT (October 27, 1995)
  • K952226 — C-FLEX SEPTAL SPLINTS (August 11, 1995)

Other clearances for product code EQJ

  • K161514 — Precision Thin Reciprocating Blade, 0.010in. (January 17, 2017)
  • K041985 — XPS CURVED BUR (August 12, 2004)
  • K974232 — ESSENTIAL SHAVER SYSTEM (January 12, 1998)
  • K960853 — ACE SYSTEM (April 3, 1996)
  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K953370 — KARL STORZ ENT SHAVER (September 6, 1995)
  • K950337 — KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (August 23, 1995)
  • K952609 — REDI DRILL DRILL SYSTEM (July 31, 1995)
  • K953096 — ESSENTIAL SHAVER SYSTEM (July 28, 1995)