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510(k) K973184

Device
PROSTATE SEEDING NEEDLE
Applicant
PROMEX, INC.
510(k) number
K973184
Product code
IWJ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-21
Date received
1997-08-25
Regulation
892.5650
Classification name
System, Applicator, Radionuclide, Manual
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH L MARK
Address
1125 Brookside Ave. Suite G500 Indianapolis IN US 46202 46202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.2001-12-03
K980997PGK DEVICE (MODIFIED)Pgk, Inc.1998-09-28
K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.1998-02-17
K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.1998-01-27
K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLC1998-01-23
K973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products1998-01-02
K973638N.I.T., INC. NEEDLE GUIDING TEMPLATEAvid N.I.T., Inc.1997-12-23
K963743MANAN PROSTATE UNI-LOCKManan Medical Products, Inc.1996-12-06
K951052WEEKS APPLICATORDuke University Medical Center1996-08-22
K961377MANAN PROSTATE LOCKING INTRODUCER SETManan Medical Products, Inc.1996-07-03
K944522MORGANSTERN PROSTATE STABILIZATION AND SEEDING KITMedical Device Technologies, Inc.1995-02-24
K940121IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERSBest Industries1994-12-30
K933410IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCESBest Industries1994-12-30
K940550COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATHCook, Inc.1994-08-17
K924290BEST INDUSTRIES CARTRIDGE & GUNBest Industries1993-06-04

Legacy Summary#

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FDA Review#

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