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U.S. Department of Health and Human Services

Product Classification
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Device implant, eye valve
Regulation Description Aqueous shunt.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeKYF
Submission Type 510(k)
Regulation Number 886.3920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Aqueous Shunts - 510(k) Submissions; Final
Third Party Review Not Third Party Eligible
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