The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Updated Sterile Endotracheal Brushes.
| Device ID | K863635 |
| 510k Number | K863635 |
| Device Name: | UPDATED STERILE ENDOTRACHEAL BRUSHES |
| Classification | Brush, Cleaning, Tracheal Tube |
| Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 615 FRONT ST. Toledo, OH 43605 |
| Contact | Norman J Huff |
| Correspondent | Norman J Huff BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 615 FRONT ST. Toledo, OH 43605 |
| Product Code | EPE |
| CFR Regulation Number | 868.5795 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-11-03 |