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U.S. Department of Health and Human Services

Product Classification

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Device cryogenic, skin tag removal, otc
Regulation Description Cryosurgical unit and accessories.
Definition Removal of skin tags.
Physical State by thermal cooling
Technical Method apply crogenic device
Target Area skin tags in visible areas
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeORE
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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