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510(k) K944238

Device
ENDOCYTE TM
Applicant
D.L. NELSON AND ASSOC., INC.
510(k) number
K944238
Product code
HCY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-15
Date received
1994-08-31
Regulation
884.4530
Classification name
Curette, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DENNIS L NELSON
Address
2902 Marlin Cir. Atlanta GA US 30341 30341

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
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
K802313UTERINE CURETTEGynemetrics, Inc.1981-01-12
K790032DISPOSABLE VACUUM CURETTEBritish Marketing Ent., Ltd.1979-02-01

Legacy Summary#

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FDA Review#

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