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510(k) K924211

Device
EJECTOR
Applicant
GLENROE TECHNOLOGIES
510(k) number
K924211
Product code
DYN  
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-31
Date received
1992-08-20
Regulation
872.6640
Classification name
Mouthpiece, Saliva Ejector
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN F BOZMAN
Address
1912 44th Ave. E Bradenton FL US 34203 34203

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflex1994-08-17
K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing AB1994-03-21
K935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.1994-03-21
K920492HIGH VACHygoplastic, Inc.1992-05-11
K921117MINIDAMDelsan Dental Systems1992-05-05
K900631SALIVA ABSORBER - DENTALKab Gloves Unltd.1990-04-04
K871315ORAL ASPIRATOREndovations1987-04-15
K870599TIP, DENTAL SUCTION APPARATUSMilitary Engineering, Inc.1987-03-23
K864300SILIVA EJECTOR/ORAL CAVITY EVACUATORArdent Intl., Inc.1986-11-24
K863768SALIVA EJECTORSThe Medical Group, Inc.1986-10-27
K863163ULS 8-86American Instrument Manufacturer'S, Inc.1986-09-22
K861934SALIVA EJECTORCarlisle Laboratories, Inc.1986-06-09
K801927SILENTSLEEPSlumber Research, Inc.1980-11-14
K800210TONGUE HOLDER/SALIVA EJECTORUnitek Corp.1980-02-06
K781592SURGICAL ASPIRATOR TIPSHenry Schein, Inc.1978-12-04

Legacy Summary#

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FDA Review#

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