The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Surgi-brush.
| Device ID | K896085 |
| 510k Number | K896085 |
| Device Name: | SURGI-BRUSH |
| Classification | Brush, Scrub, Operating-room |
| Applicant | SPARTA SURGICAL CORP. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Contact | Cindy Wilson |
| Correspondent | Cindy Wilson SPARTA SURGICAL CORP. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1989-11-08 |