FDA 510(k) Applications Submitted by Dan Wang

FDA 510(k) Number Submission Date Device Name Applicant
K181315 05/18/2018 Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd
K191819 07/05/2019 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border Winner Medical Co., Ltd.
K192463 09/09/2019 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border Winner Medical Co., Ltd.
K200330 02/10/2020 RC-Prime Root Canal Preparation Cream Pac-Dent, Inc
K070491 02/20/2007 DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 K-JUMP HEALTH CO., LTD.
K200462 02/25/2020 EtchPro Etching Gel Belport Company, Inc., Gingi-Pak
K033120 09/30/2003 SCALETRON PIEZO ULTRASOUND SCALER PAC-DENT INTERNATIONAL (SUZHOU), LTD.
K213686 11/22/2021 SKOUT Software Iterative Scopes Inc.
K990081 01/11/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990117 01/13/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K030148 01/15/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990267 01/28/1999 POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K990299 02/01/1999 POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K991457 04/26/1999 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K992100 06/21/1999 PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K061760 06/22/2006 ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 K-JUMP HEALTH CO., LTD.
K212550 08/13/2021 Hura CTP v1.0 Hura Imaging, Inc.
K031142 09/04/2003 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K023343 10/07/2002 ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K023560 10/23/2002 ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
K103498 11/29/2010 LAKONG ULTRASONIC SCALER LAKONG MEDICAL DEVICE COMPANY, LTD


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