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 Laser, Ophthalmic
510(k) Number K844358
Device Name SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
Applicant
Coherent Medical Group
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact THEODORE A BOUTACOF
Correspondent
Coherent Medical Group
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact THEODORE A BOUTACOF
Regulation Number886.4390
Classification Product Code
HQF  
Date Received11/09/1984
Decision Date 01/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-