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510(k) K833068

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

K833068 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "LAMINARIA JAPONICA CERVICAL DILATOR". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. Medi-Spec has at least 7 other 510(k) clearances on record.

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)

FDA data resources