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 biomicroscope, slit-lamp, ac-powered
510(k) Number K951340
Device Name NEITZ SLIT LAMP SL-H1
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Applicant Contact YASUO KAWANO
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Correspondent Contact YASUO KAWANO
Regulation Number886.1850
Classification Product Code
HJO  
Date Received03/24/1995
Decision Date 04/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-