The following data is part of a premarket notification filed by Ferno Ille-forge with the FDA for Model 938 Bathing System.
| Device ID | K880355 |
| 510k Number | K880355 |
| Device Name: | MODEL 938 BATHING SYSTEM |
| Classification | Bath, Hydro-massage |
| Applicant | FERNO ILLE-FORGE 2245 REACH RD. Williamsport, PA 17701 |
| Contact | Donald R Miller |
| Correspondent | Donald R Miller FERNO ILLE-FORGE 2245 REACH RD. Williamsport, PA 17701 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-16 |