Atlas FDA

SGP LENS(TM)

FDA premarket approval P840055/S003 · decided 1987-04-27

Approval details

PMA number
P840055
Supplement
S003
Supplement type
THIRTY DAY TRACK
Supplement reason
Other
Trade name
SGP LENS(TM)
Generic name
Lens, contact (other material) - daily
Applicant
The Lifestyle Co., Inc.
Date received
1986-12-03
Decision date
1987-04-27
Days to decision
145 days
Decision code
APPR
Product code
HQD
Advisory committee
Ophthalmic
Expedited review
No
Location
Morganville, NJ

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510(k) clearances by this applicant

RecordFirmDate
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) (K000529)The Lifestyle Co., Inc.2000-03-21
LIFESTYLE BREAK THRU (POLYMACON) (K965012)The Lifestyle Co., Inc.1997-03-11