PMA P860022S052

Device: BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Applicant: Bausch & Lomb
PMA number: P860022
Supplement: S052
Product code: HQD
Decision date: 2000-02-04
Generic name: Lens, contact (other material) - daily
Approval order statement: Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.

Current openFDA PMA Record#

Device: BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Applicant: Bausch & Lomb
PMA number: P860022
Supplement: S052
Product code: HQD
Generic name: Lens, contact (other material) - daily
Decision date: 2000-02-04
Decision code: APPR
Date received: 2000-01-05
Supplement type: THIRTY DAY TRACK
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.