510(k) K021750

LID CHAIN EYELID WEIGHTS by Jedmed Instrument Co. — Product Code MML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2003
Date Received
May 28, 2002
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)