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510(k) K951713

Device
BUTTON LUBRICATOR
Applicant
FIBERTECH INSTRUMENTS, INC.
510(k) number
K951713
Product code
FHX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-25
Date received
1995-04-14
Regulation
876.1500
Classification name
Jelly, Lubricating, For Transurethral Surgical Instrument
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
FRANK MAJEROWICZ
Address
5020 Campbell Blvd., Suite K Baltimore MD US 21236 21236

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081990LUBRICANO STERILE GELFarco Pharma GmbH2008-12-05
K935548CATHEJELL S STERILE LUBRICATING JELLYPharmazeutische Fabrik Montavit GmbH1994-03-30
K912132OPERAND LUBRICATING JELLYGeneral Medical Co.1991-08-07
K780386K-Y LUBRICATING JELLYJohnson & Johnson Professionals, Inc.1978-04-13
K771364LUBE JELTravenol Laboratories, S.A.1977-08-02

Legacy Summary#

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FDA Review#

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