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510(k) K864621

Device
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER
Applicant
SELDOREN LTD.
510(k) number
K864621
Product code
EHZ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-13
Date received
1986-11-24
Regulation
872.6640
Classification name
Evacuator, Oral Cavity
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEREK RAWDEN
Address
International Marketing Cons. 230 Park Ave., Suite 917 New York NY US 10136 10136

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973248IMTEC BONE COLLECTOR SYSTEMImtec Corp.1997-11-19
K941164TAP EXPRESS EJECTORTap Express, Inc.1994-05-18
K911072SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATORA & F Products1991-05-15
K903718OROSCOPE MODEL NUMBER COS-100Cygnus Instruments, Inc.1990-11-09
K892882DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102Nieusma R & D, Inc.1989-06-23
K892881DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101Nieusma R & D, Inc.1989-06-23
K880754DRI-CLAVE LIQUID KLEENZALLColumbus Dental Mfg. Co.1988-05-12
K873545PORTABLE FIELD DENTAL OPERATING & TREATMENT UNITCommercial Products & Engineering Co.1987-11-20
K874401TITANIUM SUCTION TIPImplant Innovations International, Inc.1987-11-12
K863769EVACUATOR TIPSThe Medical Group, Inc.1986-10-30
K801682SPACELINE HIGH VOLUME EVACUATION HANDPIEPacific Dental Corp.1980-08-04
K782068MVS UNIT, MODEL SEU-8 AND DEU-8, 80Dentsply Intl.1979-01-26
K781488MVS-MODEL SEU-6, DEU-6Dentsply Intl.1978-09-27
K781486STERI-VAC POWER UNITSCpac, Inc.1978-09-27
K780701DENTAL OFFICE ENVIRONMENT CONTROL UNITLaminaire Corp.1978-05-16

Legacy Summary#

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FDA Review#

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