• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameFLEXLENS (HEFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantWESTCON CONTACT LENS CO., INC.
PMA NumberP900058
Supplement NumberS001
Date Received08/27/1991
Decision Date08/29/1991
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
-
-