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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 4 of 4 Results
ProductCode: FDT Applicant: PENTAX of America, Inc. Decision Date To: 12/05/2022
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pentax medical video duedenoscope ed34-i10t2 PENTAX of America, Inc. K210710 04/09/2021
pentax medical video duodenoscope ed32-i10 Pentax of America, Inc. K202365 04/01/2021
pentax medical video duodenoscope ed34-i10t2 PENTAX of America, Inc. K192245 11/15/2019
pentax medical ed-3490tk, video duodenoscope, pentax medical ed34-i10t, video duodenoscope PENTAX of America, Inc. K181522 07/09/2018
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