• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
Trade NameFLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS
Classification Namelens, contact (other material) - daily
Generic Namemonofocal and tangent-streak biofocal rgp lens
Regulation Number886.5916
ApplicantG.T. LABORATORIES, INC.
PMA NumberP880001
Supplement NumberS037
Date Received02/05/1993
Decision Date03/31/1993
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
-
-