The following data is part of a premarket notification filed by Vancare, Inc. with the FDA for Vanna Bathing System.
Device ID | K993872 |
510k Number | K993872 |
Device Name: | VANNA BATHING SYSTEM |
Classification | Bath, Hydro-massage |
Applicant | VANCARE, INC. 1515 1ST ST. Aurora, NE 68818 |
Contact | James A Vanderheiden |
Correspondent | James A Vanderheiden VANCARE, INC. 1515 1ST ST. Aurora, NE 68818 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-15 |
Decision Date | 2000-02-16 |
Summary: | summary |