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510(k) K971245

BLINK EXTERNAL EYELID WEIGHT by Ipax, Inc. — Product Code MML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1997
Date Received
April 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Weights, Eyelid, External
Device Class
Class II
Regulation Number
886.5700
Review Panel
OP
Submission Type

Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)

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  • K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (April 12, 1999)