Device |
instrument, biopsy, reprocessed |
Definition |
Intended to obtain samples of tissue by cutting and/or other mechanical means. This device is indicated for reuse/reprocessing. 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 | NLS |
Regulation Number |
876.1075
|
Device Class |
2
|
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