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ASSORTED MOD. C LOOPS

FDA premarket approval P880072/S008 · decided 1989-12-01

Approval details

PMA number
P880072
Supplement
S008
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ASSORTED MOD. C LOOPS
Generic name
intraocular lens
Applicant
Eyekon Medical, Inc.
Date received
1989-11-01
Decision date
1989-12-01
Days to decision
30 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Clearwater, FL

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510(k) clearances by this applicant

RecordFirmDate
Temporary Keratoprosthesis (QuickSet TKP™) (K261312)Eyekon Medical, Inc.2026-07-24