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 Arthroscope
510(k) Number K940483
Device Name 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
Applicant
Neuro Navigational Corp.
3180 Pullman St.
Costa Mesa,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
Neuro Navigational Corp.
3180 Pullman St.
Costa Mesa,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/02/1994
Decision Date 05/02/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-