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, Neurosurgical, Argon
510(k) Number K860977
Device Name MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
Applicant
Britt Corp., Inc.
55 Kennedy Dr.
Smithtown,  NY  11787
Applicant Contact JEFFREY GREEN
Correspondent
Britt Corp., Inc.
55 Kennedy Dr.
Smithtown,  NY  11787
Correspondent Contact JEFFREY GREEN
Classification Product Code
LLF  
Date Received03/14/1986
Decision Date 10/16/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-