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 Lenses, Soft Contact, Daily Wear
510(k) Number K972807
Device Name (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
Applicant
Benz Research and Development Corp.
6447 Parkland Dr.
Sarasota,  FL  34243
Applicant Contact PATRICK H BENZ
Correspondent
Benz Research and Development Corp.
6447 Parkland Dr.
Sarasota,  FL  34243
Correspondent Contact PATRICK H BENZ
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/28/1997
Decision Date 10/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-