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510(k) K853708

LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE by Downs Surgical , Ltd. — Product Code KAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1986
Date Received
September 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
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 KAE

  • K851794 — 41-180 TO 41-246 VARIOUS NASAL FORCEPS (June 11, 1985)
  • K851775 — 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS (June 11, 1985)
  • K851795 — 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS (June 11, 1985)
  • K833608 — GOLD ALLIGATOR FORCEPS (January 11, 1984)
  • K833607 — MCGEE FORCEPS (January 3, 1984)
  • K833605 — CUPPED FORCEPS (January 3, 1984)
  • K822372 — OFFICE ECONO-FORCEPS (September 9, 1982)
  • K822369 — MICRO & MINI-MICRO ALLIGATOR FORCEPS (September 9, 1982)
  • K812895 — YARMO NASAL CARTILAGE SOFTENER (November 2, 1981)
  • K772397 — COTTLE COLUMELLA FORCEP (January 17, 1978)