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U.S. Department of Health and Human Services

Product Classification
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Device device, finger-sucking
Regulation Description Limb orthosis.
Regulation Medical Specialty Physical Medicine
Review Panel Dental
Product CodeLQX
Submission Type 510(k)
Regulation Number 890.3475
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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