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LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET

FDA 510(k) clearance K990224 · decided 1999-04-12

Clearance details

K-number
K990224
Device name
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
Applicant
Labtician Ophthalmics, Inc.
Decision
Substantially Equivalent
Date received
1999-01-25
Decision date
1999-04-12
Days to decision
77 days
Clearance type
Traditional
Product code
MML
Device class
2
Regulation number
886.5700
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Oakville, Ontario, CA
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GRIESHABER SCLERAL BUCKLING BALLOON CATHETER (P930024)Labtician Ophthalmics, Inc.1994-06-02