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510(k) K952227

C-FLEX ENDOLYMPHATIC SHUNT by Trebay Medical Corp. — Product Code ESZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1995
Date Received
May 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Shunt, Endolymphatic
Device Class
Class II
Regulation Number
874.3820
Review Panel
EN
Submission Type

Other clearances by Trebay Medical Corp.

  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K955560 — TREBAY SCOPE IRRIGATED CLEARING SLEEVE (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)
  • K954518 — TREBAY TOTAL RECTANGULAR HEAD (October 27, 1995)
  • K954517 — TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT (October 27, 1995)

Other clearances for product code ESZ

  • K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (January 27, 1998)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K834094 — AUSTIN ENDOLYMPH DISPERSMENT SHUNT (September 20, 1984)