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510(k) K925870

Device
SPACER
Applicant
BIP USA, INC.
510(k) number
K925870
Product code
MJG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-19
Date received
1992-11-19
Regulation
878.4800
Classification name
Device, Percutaneous, Biopsy
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GARY HORNER
Address
727 Main St. Niagara Falls NY US 14301 14301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MJG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080674PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEMPAJUNK GmbH Medizintechnologie2008-05-09
K070836EXICLIP EXCS-MClevex, Inc.2007-04-20
K983647ECHO-COAT ULTRASOUND NEEDLESSts Biopolymers1999-01-20
K955683RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAYContour Fabricators of Florida, Inc.1996-02-01
K933324SKIN BIOPSY DEVICENhr, Inc.1994-03-31
K922919DYNACYT BIOPSY ASPIRATION DEVICEBuckman Co., Inc.1993-03-31

Legacy Summary#

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FDA Review#

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