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510(k) K850068

LUNE AU CURETTES by Luneau Laboratories — Product Code HCY

K850068 is an FDA 510(k) premarket notification submitted by Luneau Laboratories for the device "LUNE AU CURETTES". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Luneau Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
January 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Luneau Laboratories

  • K844364 — SKIASCOPIC RACKS (January 2, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)

Other clearances for product code HCY

  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K944238 — ENDOCYTE TM (September 15, 1995)
  • K935822 — PHASE I CURETTE (April 28, 1994)
  • K901442 — BAXTER D & C TRAY (July 26, 1990)
  • K890384 — UTERINE CURETTE (February 13, 1989)
  • K881794 — IVORY FINDER SET (July 8, 1988)
  • K862297 — THE D & C PAD-SAC (July 7, 1986)
  • K841004 — SURGICAL CURETTE, VARIOUS (May 11, 1984)
  • K802313 — UTERINE CURETTE (January 12, 1981)
  • K790032 — DISPOSABLE VACUUM CURETTE (February 1, 1979)

FDA data resources