The following data is part of a premarket notification filed by Ferno with the FDA for Ferno Ille Hi-lo Jr. Mobile Whirlpool, Model 403.
Device ID | K914125 |
510k Number | K914125 |
Device Name: | FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 |
Classification | Bath, Hydro-massage |
Applicant | FERNO 70 WEIL WAY Wilmington, OH 45177 |
Contact | Eric N Besanko |
Correspondent | Eric N Besanko FERNO 70 WEIL WAY Wilmington, OH 45177 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-13 |
Decision Date | 1991-10-25 |