PMA N17945

Device
Adapettes Lubricating And Rewetting Solution
Applicant
ALCON LABORATORIES
PMA number
N17945
Supplement
S029
Decision date
1996-01-04

Current openFDA PMA Record

Device
ADAPETTES LUBRICATING AND REWETTING SOLUTION
Applicant
Alcon Laboratories
PMA number
N17945
Supplement
S029
Product code
LPN
Generic name
Accessories, soft lens products
Decision date
1996-01-04
Decision code
APPR
Date received
1995-08-25
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO USE 100% ETHYLENE OXIDE AS AN ALTERNATE STERILIZATION METHOD OF PRIMARY PACKAGING COMPONENTS - THE ALTERNATE STERILIZATION METHOD WILL BE PERFORMED AS ISOMEDIX, 2072 SOUTHPORT RD., SPARTANBURG, SC

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