The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Medical Products Foam Double Scrub #450.
| Device ID | K831226 |
| 510k Number | K831226 |
| Device Name: | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 |
| Classification | Brush, Scrub, Operating-room |
| Applicant | BALLARD MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-15 |
| Decision Date | 1983-05-16 |