• 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
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameB&L 58(TM) (ETAFILCONA) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Nameetafilcon a contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP850039
Date Received06/06/1985
Decision Date08/16/1985
Withdrawal Date 11/18/2009
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 85M-0420
Notice Date 09/23/1985
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
-
-