The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Foam Care One Step Prep.
| Device ID | K843636 |
| 510k Number | K843636 |
| Device Name: | FOAM CARE ONE STEP PREP |
| Classification | Brush, Scrub, Operating-room |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Ernest M Chamberlai |
| Correspondent | Ernest M Chamberlai BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-11-16 |