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SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

FDA premarket approval P860040/S012 · decided 1994-01-27

Approval details

PMA number
P860040
Supplement
S012
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES
Generic name
Lenses, soft contact, daily wear
Applicant
Wavetouch Technologies, LLC
Date received
1993-04-28
Decision date
1994-01-27
Days to decision
274 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
San Diego, CA

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