Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Absorber, Saliva, Paper
510(k) Number K954068
Device Name GENERAL HYGIENE KIT
Applicant
Physician Industries, Inc.
101 N. 700 Wst
P.O. Box 540793
North Salt Lake,  UT  84054
Applicant Contact BRIAN BAKER
Correspondent
Physician Industries, Inc.
101 N. 700 Wst
P.O. Box 540793
North Salt Lake,  UT  84054
Correspondent Contact BRIAN BAKER
Regulation Number872.6050
Classification Product Code
KHR  
Date Received08/30/1995
Decision Date 11/08/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-