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, Contact (Other Material) - Daily
510(k) Number K963744
Device Name BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
Applicant
Benz Research and Development Corp.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
Benz Research and Development Corp.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/17/1996
Decision Date 07/31/1997
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
-
-