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SAULFON PW-70 A&B

FDA premarket approval P840031 · decided 1985-04-12

Approval details

PMA number
P840031
Trade name
SAULFON PW-70 A&B
Generic name
Lenses, soft contact, extended wear
Applicant
Lombart Lenses, Ltd.
Date received
1984-07-05
Decision date
1985-04-12
Days to decision
281 days
Decision code
APWD
Product code
LPM
Advisory committee
Ophthalmic
Expedited review
No
Location
Norfolk, VA

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510(k) clearances by this applicant

RecordFirmDate
LL BI-FOCAL, DAILY WEAR CONTACT LENS (K971647)Lombart Lenses, Ltd.1997-07-15
SOFT-55 DAILY WEAR CONTACT LENS (K961428)Lombart Lenses, Ltd.1996-05-21
LL-55 (METHAFILCON A) FOR DAILY WEAR (K941877)Lombart Lenses, Ltd.1994-06-14