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 Reader, Prism, Ophthalmic
510(k) Number K000544
Device Name BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
Applicant
Labtician Ophthalmics, Inc.
2140 Winston Park Dr., Unit 6
Oakville, Ontario,  CA L6H 5V5
Applicant Contact R. DAVID SCULATI
Correspondent
Labtician Ophthalmics, Inc.
2140 Winston Park Dr., Unit 6
Oakville, Ontario,  CA L6H 5V5
Correspondent Contact R. DAVID SCULATI
Regulation Number886.5810
Classification Product Code
HJX  
Date Received02/18/2000
Decision Date 03/09/2000
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
-
-