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510(k) K833068

LAMINARIA JAPONICA CERVICAL DILATOR by Medi-Spec — Product Code HDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
September 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Cervical, Hygroscopic-Laminaria
Device Class
Class II
Regulation Number
884.4260
Review Panel
OB
Submission Type

Other clearances by Medi-Spec

  • K812694 — WHISK-R (October 26, 1981)
  • K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX) (October 8, 1981)
  • K801554 — STERILE CAST PADDING (August 4, 1980)
  • K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT (April 24, 1980)
  • K800490 — STERILE DRESSING PACK (March 12, 1980)
  • K790952 — CLAMP COVERS (June 5, 1979)
  • K780548 — DISPOSA-LOOPS (August 21, 1978)

Other clearances for product code HDY

  • K040625 — ATAD ARD CATHETER (January 18, 2005)
  • K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (June 25, 2002)
  • K011512 — MMODIFICATION TO LAMINARIA (July 9, 2001)
  • K955072 — LAMINARIA (May 22, 1996)
  • K892220 — LAMINARIA TENT (June 14, 1989)
  • K881295 — LAMINARIA CUREX (August 10, 1988)
  • K881312 — LAMINARIA (May 23, 1988)
  • K880196 — LAMINARIA (May 6, 1988)
  • K845006 — SUN MEDICAL LAMINARIA CERVICAL DILATOR (May 1, 1985)
  • K782067 — DILATOR, MIZUTANI LAMINARIA TENT (January 3, 1979)