Atlas FDA

SOFTCON BANDAGE LENS

FDA premarket approval N17375/S004 · decided 1981-01-27

Approval details

PMA number
N17375
Supplement
S004
Trade name
SOFTCON BANDAGE LENS
Generic name
Lenses, soft contact, daily wear
Applicant
Ciba Vision Care
Date received
1980-04-17
Decision date
1981-01-27
Days to decision
285 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Duluth, GA

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510(k) clearances by this applicant

RecordFirmDate
PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346)Ciba Vision Care1987-02-27
IN A WINK LUBRICATING & REWETTING DROPS (K853445)Ciba Vision Care1985-11-29