FDA.reportPublic FDA data

510(k) K850068

Device
LUNE AU CURETTES
Applicant
LUNEAU LABORATORIES
510(k) number
K850068
Product code
HCY  
Decision
Substantially Equivalent (SESE)
Decision date
1985-04-08
Date received
1985-01-08
Regulation
884.4530
Classification name
Curette, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHAMBORD
Address
2000 L. St. NW Suite 715 Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980096OAC (OPTICAL ASPIRATING CURETTE)Imagyn Medical Technologies, Inc.1998-05-01
K944238ENDOCYTE TMD.L. Nelson and Assoc., Inc.1995-09-15
K935822PHASE I CURETTEPhase I Corp.1994-04-28
K901442BAXTER D & C TRAYBaxter Healthcare Corp1990-07-26
K890384UTERINE CURETTEKinetic Medical Products1989-02-13
K881794IVORY FINDER SETIvory Instruments Co.1988-07-08
K862297THE D & C PAD-SACNu-Gyn-Tek, Inc.1986-07-07
K841004SURGICAL CURETTE, VARIOUSPremier Dental Products Co.1984-05-11
K802313UTERINE CURETTEGynemetrics, Inc.1981-01-12
K790032DISPOSABLE VACUUM CURETTEBritish Marketing Ent., Ltd.1979-02-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases