NML · Class II · 21 CFR 876.5010

FDA Product Code NML: Catheter, Biliary, Reprocessed

Same As "fge" Except Being 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).

Leading manufacturers include Sterilmed, Inc..

1
Total
1
Cleared
264d
Avg days
2002
Since