The following data is part of a premarket notification filed by Windmere Corp. with the FDA for Windmere Model Ds-2 Foot Bath.
Device ID | K980769 |
510k Number | K980769 |
Device Name: | WINDMERE MODEL DS-2 FOOT BATH |
Classification | Bath, Hydro-massage |
Applicant | WINDMERE CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Contact | Richard C Lanzillotto |
Correspondent | Richard C Lanzillotto WINDMERE CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-27 |
Decision Date | 1998-03-27 |