FDA.reportPublic FDA data

510(k) K881784

Device
Klein Needle
Applicant
E.L. MEDICO INTL., INC.
510(k) number
K881784
Product code
GDM
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-02
Date received
1988-04-27
Regulation
878.4800
Classification name
Needle, Aspiration And Injection, Reusable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEFF KLEIN
Address
Post Office Box 1268 San Clemente CA US 92672 92672

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071732MARROWMINERStemcor Systems, Inc.2007-09-24
K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.1997-06-03
K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare Corp1995-09-22
K953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.1995-08-07
K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.1994-06-16
K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.1993-07-06
K923872BONE MARROW BIOPSY SYSTEMThe Straumann Co.1992-12-15
K915572BECTON DICKINSON MODIFIED MENGHINI NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic1992-02-03
K904667NA NEEDLESOlympus Corp.1990-12-12
K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EDowns Surgical , Ltd.1990-10-31
K903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UDowns Surgical , Ltd.1990-10-31
K903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VDowns Surgical , Ltd.1990-10-31
K903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UDowns Surgical , Ltd.1990-10-31
K902177MANAN BONE BIOPSY NEEDLEManan Medical Products, Inc.1990-09-05
K901995PLEURA BIOPSY DEVICEMill-Rose Laboratory1990-07-10