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510(k) K953064

Device
BIOACCESS MARROW HARVEST SYSTEM
Applicant
BIOACCESS, INC.
510(k) number
K953064
Product code
GDM  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-07
Date received
1995-06-30
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
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PETER J CARNES
Address
8400 Cedar St. Silver Spring MD US 20910 20910

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K895752DIAMOND BLADE SURGICAL KNIVESMagnum Diamond, Inc.1989-10-17

Legacy Summary#

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FDA Review#

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