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510(k) K802140

LEKSELL STEREOTACTIC SYSTEM by Downs Surgical , Ltd. — Product Code IWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1981
Date Received
September 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type

Other clearances by Downs Surgical , Ltd.

  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K900610 — SHEPPERD CANNULA STILLETTE & OBDURATOR SET (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900615 — SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE (October 22, 1990)

Other clearances for product code IWY

  • K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (December 28, 1992)
  • K884493 — HEAD HOLDING DEVICE/SLEEP APNEA (January 12, 1989)
  • K884847 — MTD HEDREST (January 9, 1989)
  • K864527 — DUOCEPH (January 7, 1987)
  • K850197 — KELLER CEPHALOMETRIC DEVICE (March 22, 1985)
  • K844549 — HEAD-SPINE STABILIZER HSS-1 (March 1, 1985)
  • K843340 — PORTA-STAT (November 27, 1984)
  • K834559 — DELUXE WALL-MOUNTED CEPHALOMETER (February 21, 1984)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 1978)