The following data is part of a premarket notification filed by Penner Manufacturing, Inc. with the FDA for Superior Bath, Model 6300.
| Device ID | K012061 |
| 510k Number | K012061 |
| Device Name: | SUPERIOR BATH, MODEL 6300 |
| Classification | Bath, Hydro-massage |
| Applicant | PENNER MANUFACTURING, INC. 1500 WOODMEN TOWER Ohaha, NE 68102 |
| Contact | Vickie Brady |
| Correspondent | Brian R Biersach UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-07-19 |