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510(k) K954518

TREBAY TOTAL RECTANGULAR HEAD by Trebay Medical Corp. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
September 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
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)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 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)
  • K954517 — TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT (October 27, 1995)
  • K952226 — C-FLEX SEPTAL SPLINTS (August 11, 1995)

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