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 preamplifier, battery-powered, ophthalmic
510(k) Number K900279
Device Name OCULINUM INJECTION AMPLIFIER
Applicant
OCULINUM, INC.
901 GRAYSON ST.
BERKELEY,  CA  94710
Applicant Contact SCOTT, M.D.
Correspondent
OCULINUM, INC.
901 GRAYSON ST.
BERKELEY,  CA  94710
Correspondent Contact SCOTT, M.D.
Regulation Number886.1640
Classification Product Code
HLW  
Date Received01/08/1990
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-