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510(k) K780386

Device
K-Y LUBRICATING JELLY
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
510(k) number
K780386
Product code
FHX  
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-13
Date received
1978-03-10
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
Third party reviewed
No

Applicant Contact#

Address
325 Paramount Dr. Raynham MA US 02767 02767

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
K951713BUTTON LUBRICATORFibertech Instruments, Inc.1995-04-25
K935548CATHEJELL S STERILE LUBRICATING JELLYPharmazeutische Fabrik Montavit GmbH1994-03-30
K912132OPERAND LUBRICATING JELLYGeneral Medical Co.1991-08-07
K771364LUBE JELTravenol Laboratories, S.A.1977-08-02

Legacy Summary#

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FDA Review#

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