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510(k) FDA Premarket Notification P030011

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The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858000003046 P030011 000
00858000003008 P030011 002
00858000003213 P030011 011
00858000003138 P030011 011
00858000003190 P030011 011
00858000003206 P030011 011
00858000003220 P030011 011
00858000003237 P030011 011
00858000003077 P030011 011
00858000003107 P030011 011
00858000003114 P030011 011
00858000003282 P030011 020
00858000003275 P030011 020
00858000003268 P030011 020
00858000003121 P030011 020
00858000003251 P030011 020
00858000003299 P030011 020
00858000003305 P030011 020
00858000003015 P030011 020
00858000003022 P030011 020
00858000003244 P030011 020
00858000003084 P030011 020
00858000003053 P030011 070
00858000003091 P030011 070

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