• 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 Laser, Ophthalmic
510(k) Number K864063
Device Name ORION 3001, LASER PHOTOCOAGULATOR
Applicant
G. RODENSTOCK INSTRUMENTE GMBH
DRACHENSEESTRABE 10-12
POSTFACH 701560, D-8000
MUNCHEN 70, WEST GERMANY,  DE
Applicant Contact PRATSCH
Correspondent
G. RODENSTOCK INSTRUMENTE GMBH
DRACHENSEESTRABE 10-12
POSTFACH 701560, D-8000
MUNCHEN 70, WEST GERMANY,  DE
Correspondent Contact PRATSCH
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/20/1986
Decision Date 11/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-