GCL · Class II · 21 CFR 876.1500

FDA Product Code GCL: Esophagoscope, General & Plastic Surgery

If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include C.R. Bard, Inc..

4
Total
4
Cleared
121d
Avg days
1992
Since