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510(k) K904826

TKO TELESCOPING LITHOTOMY STIRRUP by D.L. Nelson and Assoc., Inc. — Product Code FWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1990
Date Received
October 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Operating Room Accessories Table Tray
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by D.L. Nelson and Assoc., Inc.

  • K944238 — ENDOCYTE TM (September 15, 1995)
  • K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)

Other clearances for product code FWZ

  • K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
  • K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (July 30, 1993)
  • K926225 — SPONGE COUNTER (March 5, 1993)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)