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510(k) K923835

Device
THE ELEVENTH FINGER
Applicant
GUARDIAN ANGEL PRODUCTS, INC.
510(k) number
K923835
Product code
GDF  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-09
Date received
1992-07-31
Regulation
878.4800
Classification name
Guide, Needle, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HOWARD M HOLSTEIN
Address
Columbia Sq. 555 Thirteeth St. NW Washington DC US 20004 20004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K900903KOPANS HOOKWIRE LESION LOCALIZATION NEEDLEMilex Products, Inc.1990-05-03

Legacy Summary#

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FDA Review#

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