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 nasopharyngoscope (flexible or rigid)
510(k) Number K962255
Device Name CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
Applicant
CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS,  MN  55427 -8656
Applicant Contact JOHN VANDEN HOEK
Correspondent
CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS,  MN  55427 -8656
Correspondent Contact JOHN VANDEN HOEK
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/12/1996
Decision Date 09/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-