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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 808CC/808KK/808CL/808CM/808CH/808EH/808BH/808DH/808AL/808CUTE/808VEH/808XF/808VEL/808FL/Superme ice-kk/808SS/808YK
Classification Name: POWERED LASER SURGICAL INSTRUMENT
Product Code: GEX
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: BEIJING HONKON TECHNOLOGIES CO., LTD.
Registered Establishment Number: 3009488834
Premarket Submission Number: K131838
Owner/Operator: Beijing Honkon Technologies Co., Ltd.
Owner/Operator Number: 10045305
Establishment Operations: Manufacturer
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