The following data is part of a premarket notification filed by Sparta Instrument Corp. with the FDA for Sparta Bronchial Brush.
| Device ID | K781365 |
| 510k Number | K781365 |
| Device Name: | SPARTA BRONCHIAL BRUSH |
| Classification | Bronchoscope Accessory |
| Applicant | SPARTA INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-07 |
| Decision Date | 1978-08-14 |