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

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


New Search Back to Search Results
 
Trade NameFLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberN18143
Supplement NumberS033
Date Received08/20/1996
Decision Date02/10/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to reduce the minimum gamma radiation sterilization dose specification from 25. 0 kgy to 16. 2 kgy for the majority of primary packaging components (bottles, plugs and closures), and from 25. 0 kgy to 18. 0 kgy for the 8 oz. High density polyethylene (hdpe) bottles and the 15 oz. Low density polyethylene (ldpe) bottles.
-
-