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510(k) K954068

Device
GENERAL HYGIENE KIT
Applicant
PHYSICIAN INDUSTRIES, INC.
510(k) number
K954068
Product code
KHR  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1995-11-08
Date received
1995-08-30
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
BRIAN BAKER
Address
101 N. 700 Wst P.O. Box 540793 North Salt Lake UT US 84054 84054

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
K980783SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5Irt Management Corp.1998-04-21
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

Legacy Summary#

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FDA Review#

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