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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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acuity 200™ (fluoroxyfocon a) rigid gas permeable contact lens; acuity 100™ (hexafocon a) rigid gas permeable contact lens; acuity 200™ with tangible® hydra-peg® (fluoroxyfocon a) rigid gas permeable contact lens; acuity 100™ with tangible® hydra-peg® (hexafocon a) rigid gas permeable contact lens Acuity Polymers, Inc. k240618 04/03/2024
celerity chemical indicator for enspire 3000 clcsps STERIS Corporation k240032 04/17/2024
meticuly patient-specific titanium maxillofacial mesh implant Meticuly Co., Ltd. k232889 04/30/2024
disposable enteral feeding sets Beijing L&Z Medical Technology Development Co., Ltd. k240052 07/03/2024
lightin system, lightin, lightin generator Solmedix Co., Ltd. k232177 07/10/2024
nasal aspirator (bc-021, bc-022, bc-023, bc-024, bc-025, bc-026) Dongguanshi Yiyingmei Technology Co., Ltd. k242028 11/19/2024
alcon 27ga chandelier (8065000252); alcon 27+ ds wide angle endoilluminator (8065000253); alcon 27+ ds endoilluminator (8065000256); Alcon Laboratories, Inc. k242184 12/04/2024
mxact total prosthesis offcenter, mxact total prosthesis center and mxact pro total prosthesis kit Med-El Elektromedizinische Geräte GmbH k241269 01/17/2025
3m™ attest™ super rapid steam extended cycle clear challenge pack 1492pcde; 3m™ attest™ auto-reader 490; 3m™ attest™ auto-reader 490h; 3m™ attest™ mini auto-reader 490m 3M Company k243501 01/28/2025
disposable blood lancet (soft pro); disposable blood lancet (softsure); disposable blood lancet (softsure pro); disposable blood lancet (softsense) SteriLance Medical (Suzhou), Inc. k244031 02/26/2025

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