Device |
forceps, biopsy, bronchoscope (non-rigid), reprocessed |
Definition |
Same as BWH except it is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Product Code | NLE |
Regulation Number |
874.4680
|
Device Class |
2
|
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