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U.S. Department of Health and Human Services

Product Classification
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Device keratome,water jet
Regulation Description Keratome.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMYD
Submission Type 510(k)
Regulation Number 886.4370
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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