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510(k) K821358

MODIFIED RONGEURS FOR SPINAL & ORTH. S. by Downs Surgical , Ltd. — Product Code EMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Rongeur, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
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 EMH

  • K890255 — BONE RONGEUR, SINGLE-ACTION (January 27, 1989)
  • K890256 — BONE RONGEUR, DOUBLE-ACTION (January 27, 1989)
  • K854887 — MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (February 28, 1986)
  • K851710 — 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (June 11, 1985)
  • K834190 — JAKOBI SURG. INSTRUMENTS #8 15 (March 6, 1984)
  • K834366 — SURGICAL INSTRUMENTS & ACCESSORIES (February 27, 1984)
  • K771522 — FORCEPS, STYLE #849 (August 16, 1977)