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U.S. Department of Health and Human Services

Product Classification

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Device unit, cryotherapy, ophthalmic
Regulation Description Cryophthalmic unit.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQA
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4170
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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