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510(k) K802313

Device
UTERINE CURETTE
Applicant
GYNEMETRICS, INC.
510(k) number
K802313
Product code
HCY  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-12
Date received
1980-09-23
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K850068LUNE AU CURETTESLuneau Laboratories1985-04-08
K841004SURGICAL CURETTE, VARIOUSPremier Dental Products Co.1984-05-11
K790032DISPOSABLE VACUUM CURETTEBritish Marketing Ent., Ltd.1979-02-01

Legacy Summary#

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FDA Review#

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