Lune Au Curettes

FDA 510(k) K850068 · Luneau Laboratories

Substantially Equivalent

510(k) numberK850068

Submission

Device name
Lune Au Curettes
Applicant
Luneau Laboratories
Washington, DC, US
Received
January 8, 1985
Decision date
April 8, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HCY – Curette, Uterine
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HCY

510(k)DeviceApplicantDecision
K980096Oac (Optical Aspirating Curette)HCY · Traditional Imagyn Medical Technologies, Inc.05/01/1998SE
K944238Endocyte TMHCY · Traditional D.L. Nelson and Assoc., Inc.09/15/1995SE
K935822Phase I CuretteHCY · Traditional Phase I Corp.04/28/1994SE
K901442Baxter D & C TrayHCY · Traditional Baxter Healthcare Corp07/26/1990SE
K890384Uterine CuretteHCY · Traditional Kinetic Medical Products02/13/1989SE
K881794Ivory Finder SetHCY · Traditional Ivory Instruments Co.07/08/1988SE
K862297The D & C Pad-SacHCY · Traditional Nu-Gyn-Tek, Inc.07/07/1986SE
K841004Surgical Curette, VariousHCY · Traditional Premier Dental Products Co.05/11/1984SE
K802313Uterine CuretteHCY · Traditional Gynemetrics, Inc.01/12/1981SE
K790032Disposable Vacuum CuretteHCY · Traditional British Marketing Ent., Ltd.02/01/1979SE

More from British Marketing Ent., Ltd.

510(k)DeviceDecision
K844365Color Vision TestersHIT · Traditional 01/02/1985SE
K844364Skiascopic RacksHMH · Traditional 01/02/1985SE
K844362Ophthalmic ChairHMF · Traditional 12/11/1984SE
K844363Ophthalmic StandHMF · Traditional 12/05/1984SE

Questions and answers

When was Lune Au Curettes cleared by the FDA?

Lune Au Curettes (K850068) received a 510(k) decision of Substantially Equivalent on April 8, 1985, 90 days after the submission was received.

What is the product code of K850068?

The FDA product code is HCY – Curette, Uterine, a Class I (low risk) device regulated under 21 CFR 884.4530.