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510(k) K980783

Device
Simplex Saliva Absorber/collector, Model Ssa-5
Applicant
IRT MANAGEMENT CORP.
510(k) number
K980783
Product code
KHR
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-21
Date received
1998-03-02
Regulation
872.6050
Classification name
Absorber, Saliva, Paper
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NICHOLAS G LEVANDOSKI, PH.D.
Address
470 Ansin Blvd., Suite G Hallandale FL US 33009 33009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KHR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954068GENERAL HYGIENE KITPhysician Industries, Inc.1995-11-08
K953812GAUZE SPONGERemington Medical, Inc.1995-10-02
K891054NON-STERILE GAUZE SPONGEDispomed, Inc.1989-05-01
K891354ORTHODONTIC COTTON ROLL HOLDERSAmerican Orthodontics1989-04-17
K890734DRY TIPSMicrocopy, Div. Neo-Flo, Inc.1989-03-10
K870383ALGINATE WOOL FIBERAdri1987-04-30
K850988BOVO MOISTURE GUARDE.H. Medical Co.1985-04-16
K780400DEN-Z-ORBNice-Pak Products, Inc.1978-03-27
K771908ISO-SHIELD SALIVA ABSORBERS3M Company1977-11-07