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510(k) K141028

Device
COLONGLIDE LUBRICANT
Applicant
PEDIATRIC PHARMACEUTICALS INC.
510(k) number
K141028
Product code
KMJ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-24
Date received
2014-04-22
Regulation
880.6375
Classification name
Lubricant, Patient
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT M HARRIS
Address
2137 Rte. 35 Holmdel NJ US 07733 07733

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142473Lubricating JellySion Biotext Medical , Ltd.2015-04-13
K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.2013-10-03
K121390LUBE JELLY SURINGENurse Assist, Inc.2012-08-10
K113689DUKAL LUBRICATING JELLYDukal Corporation2012-05-04
K112110STERILE LUBRICATING JELLYJianerkang Medical Dressing Company2012-04-10
K103718DYNACOR LUBRICATION GELMedline Industries, Inc.2011-05-10
K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation2010-12-23
K092488DYNAREX STERILE LUBRICATING JELLYDynarex Corporation2009-12-18
K083189STERI-LUB LUBRICATION GELAvail Medical Products, Inc.2008-11-21
K073684SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGELSheffield Industries, Div. of Faria , Ltd.2008-05-22
K080042SPIRUS MEDICAL SURGICAL INSTRUMENTSpirus Medical, Inc.2008-04-03
K042563DUREX PLAY WARMER LUBRICANTSsl Americas, Inc.2005-02-23
K041060E-Z LUBRICATING JELLYChester Labs, Inc.2004-05-07
K020586GOOD LUBRICATIONSBiofilm, Inc.2003-01-24
K974768PDI STERILE LUBRICATING JELLYNice-Pak Products, Inc.1998-01-16

Legacy Summary#

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FDA Review#

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