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510(k) K863090

Device
PERCU GUIDE I (LOOP TYPE)
Applicant
E-Z-EM, INC.
510(k) number
K863090
Product code
GDF  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-29
Date received
1986-08-13
Regulation
878.4800
Classification name
Guide, Needle, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JACK T BERGER
Address
717 Main St. Westbury NY US 11590 11590

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.2003-07-23
K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.1995-05-26
K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco Healthc1995-03-15
K945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.1994-11-22
K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.1994-11-04
K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.1994-02-22
K935457LOCALIZATION WIRE OR MARKER - SURGICALBip USA, Inc.1994-02-17
K923840NEEDLE-GRABBERGuardian Angel Products, Inc.1993-07-13
K923835THE ELEVENTH FINGERGuardian Angel Products, Inc.1993-07-09
K925875HORIZONTAL NEEDLE GUIDE ATTACHMENTBip USA, Inc.1993-04-06
K924270BREAST LESION LOCALIZATION NEEDLECore Medical, Inc.1992-09-23
K923120MICROGUIDE LESION MARKING SYSTEMAngiodynamics, Div. E-Z-Em, Inc.1992-09-01
K914941SIMON BREAST LESION LOCALIZATION NEEDLEManan Medical Products, Inc.1992-05-14
K920816PERCUGUIDE LESION MARKINGE-Z-Em, Inc.1992-04-21
K904172ACCUPLACE (TM)Dlp, Inc.1990-11-21

Legacy Summary#

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FDA Review#

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