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510(k) K834361

Device
JSB JET SYRINGE
Applicant
C.B.S. BIOTECHNICS, INC.
510(k) number
K834361
Product code
EGM  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-05
Date received
1983-10-27
Regulation
872.4475
Classification name
Injector, Jet, Mechanical-powered
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EGM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243427QuickSleeper 5Dentalhitec2025-08-01
K083811W&H HANDPIECE ANESTO, MODEL: RA-5W&H Dentalwerk Buermoos GmbH2010-01-14
K964802CYBERJET LOCAL ANESTHESIA SYSTEMIntra Vantage, Inc.1997-05-27
K962017HYPODERMIC JET INJECTION APPARATUSAmerican Jet Injector Corp.1996-07-26
K904279PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.1990-12-07
K864294HENKE-JECT PRESSURE SYRINGE (MODIFICATION)Smith & Nephew, Inc.1987-11-04
K864732GRADTECH SYRINGE SYSTEMGradtech1987-04-15
K864861INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEMInstrumentations Unltd.1987-02-13
K821273MAYO SCISSOR STRAIGHT 6 3/4Conphar, Inc.1982-05-28
K790193MIZZY SYRIJET MARK IVMizzy, Inc.1979-04-23

Legacy Summary#

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FDA Review#

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