The following data is part of a premarket notification filed by Penner Manufacturing, Inc. with the FDA for Cascade Bath, Model 6900.
Device ID | K012057 |
510k Number | K012057 |
Device Name: | CASCADE BATH, MODEL 6900 |
Classification | Bath, Hydro-massage |
Applicant | PENNER MANUFACTURING, INC. 1500 WOODMEN TOWER Ohaha, NE 68102 |
Contact | Vickie J 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 |