The following data is part of a premarket notification filed by Penner Manufacturing, Inc. with the FDA for Pacific Recumbent Height-adjustable Bath System.
| Device ID | K040772 |
| 510k Number | K040772 |
| Device Name: | PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM |
| Classification | Bath, Hydro-massage |
| Applicant | PENNER MANUFACTURING, INC. 1500 WOODMEN TOWER Ohaha, NE 68102 |
| Contact | Vickie J Brady |
| Correspondent | Chantel Carson 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 | 2004-03-26 |
| Decision Date | 2004-04-05 |