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510(k) FDA Premarket Notification P970003

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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
05425025750160 P970003 016
05425025750245 P970003 039
05425025750016 P970003 040
05425025750092 P970003 040
05425025750108 P970003 040
05425025750023 P970003 047
05425025750122 P970003 064
05425025750115 P970003 064
05425025750047 P970003 076
05425025750030 P970003 076
05425025750153 P970003 100
05425025750139 P970003 100
05425025750054 P970003 119
05425025750184 P970003 148
05425025750191 P970003 148
05425025750214 P970003 154
05425025750382 P970003 154
05425025750368 P970003 173
05425025750061 P970003 173
05425025750375 P970003 183
05425025750405 P970003 210
05425025750177 P970003 210
05425025750399 P970003 211
05425025750481 P970003 215
05425025750429 P970003 218
05425025750511 P970003 225
05425025750504 P970003 226
05425025750443 P970003 226
05425025750528 P970003 231
05425025750535 P970003 234
05425025750634 P970003 241

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