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510(k) K782067

DILATOR, MIZUTANI LAMINARIA TENT by British Marketing Ent., Ltd. — Product Code HDY

K782067 is an FDA 510(k) premarket notification submitted by British Marketing Ent., Ltd. for the device "DILATOR, MIZUTANI LAMINARIA TENT". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260. British Marketing Ent., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1979
Date Received
December 13, 1978
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 British Marketing Ent., Ltd.

  • K790032 — DISPOSABLE VACUUM CURETTE (February 1, 1979)

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)
  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)

FDA data resources