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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device weights, eyelid, external
Definition Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Product CodeMML
Regulation Number 886.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTOMED LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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