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 Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K844321
Device Name CUSTOM LITE
Applicant
BUCHMANN OPTICAL INDUSTRIES
216 MIDLAND AVE.
SADDLE BROOK,  NY  07662
Applicant Contact CEURREMANS
Correspondent
BUCHMANN OPTICAL INDUSTRIES
216 MIDLAND AVE.
SADDLE BROOK,  NY  07662
Correspondent Contact CEURREMANS
Regulation Number886.5844
Classification Product Code
HQG  
Date Received11/06/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-