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510(k) K842701

HOPPENSTEIN MICROSURGICAL SPINAL INSTRU by Downs Surgical , Ltd. — Product Code FZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1984
Date Received
July 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 FZS

  • K932493 — SURGICAL CURETTE (January 7, 1994)
  • K902000 — KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (August 21, 1990)
  • K892521 — CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (May 1, 1989)
  • K891888 — CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (April 12, 1989)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K890366 — ADENOID CURETTE (February 3, 1989)
  • K875292 — MICRODISCECTOMY CURETTE SET (January 29, 1988)
  • K871925 — STRAIGHT CUP CURRETTE, 1.7MM (June 1, 1987)
  • K854899 — NOVAK CURETTE (December 24, 1985)
  • K854888 — RANDALL CURETTE (December 24, 1985)