The following data is part of a premarket notification filed by K. W. Griffen Co. with the FDA for Bioscrub Surgical Scrub Brush.
| Device ID | K870258 |
| 510k Number | K870258 |
| Device Name: | BIOSCRUB SURGICAL SCRUB BRUSH |
| Classification | Brush, Scrub, Operating-room |
| Applicant | K. W. GRIFFEN CO. C/O CORNELIA DAMSKY, INC. 56 WESTCOTT ROAD Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky K. W. GRIFFEN CO. C/O CORNELIA DAMSKY, INC. 56 WESTCOTT ROAD Stamford, CT 06902 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-23 |
| Decision Date | 1987-02-24 |