ORC · Class II · 21 CFR 878.5070

FDA Product Code ORC: Air Filter Portable Apparatus

The Sytem Is Intended To Control The Surgical Environment To Prevent Bacterial Contamination During Surgical Procedures.

Leading manufacturers include Toul Meditech AB.

6
Total
6
Cleared
294d
Avg days
2011
Since

FDA 510(k) Cleared Air Filter Portable Apparatus Devices (Product Code ORC)

6 devices
1–6 of 6
Cleared May 10, 2019
SteriStay
K190027
Toul Meditech AB
General & Plastic Surgery · 123d

About Product Code ORC - Regulatory Context