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510(k) K874630

RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS by Downs Surgical , Ltd. — Product Code HAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
November 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

Other clearances by Downs Surgical , Ltd.

  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K900610 — SHEPPERD CANNULA STILLETTE & OBDURATOR SET (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)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)

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  • K943115 — AUTO SUTURE PITUITARY SPINAL RONGEUR (July 25, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942970 — AUTO SUTURE SPINAL ELEVATOR (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)