The following data is part of a premarket notification filed by Dutton-lainson Co. with the FDA for Sanitas Whirpool Bathing System.
Device ID | K930624 |
510k Number | K930624 |
Device Name: | SANITAS WHIRPOOL BATHING SYSTEM |
Classification | Bath, Hydro-massage |
Applicant | DUTTON-LAINSON CO. 451 WEST SECOND ST. Hastings, NE 68902 |
Contact | Ron Haase |
Correspondent | Ron Haase DUTTON-LAINSON CO. 451 WEST SECOND ST. Hastings, NE 68902 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-08 |
Decision Date | 1994-07-01 |