The following data is part of a premarket notification filed by Arjo-century, Inc. with the FDA for Arjo-century Podiatric Whirlpool Systems.
| Device ID | K923159 |
| 510k Number | K923159 |
| Device Name: | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS |
| Classification | Bath, Hydro-massage |
| Applicant | ARJO-CENTURY, INC. 8130 LEHIGH AVE. Morton Grove, IL 60053 |
| Contact | Gregory D Holmer |
| Correspondent | Gregory D Holmer ARJO-CENTURY, INC. 8130 LEHIGH AVE. Morton Grove, IL 60053 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-08-06 |