The following data is part of a premarket notification filed by Universal-kundle Corp. with the FDA for Sears 5 Foot Acrylic Bathtub/whirlpool.
Device ID | K791718 |
510k Number | K791718 |
Device Name: | SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL |
Classification | Bath, Hydro-massage |
Applicant | UNIVERSAL-KUNDLE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-28 |
Decision Date | 1979-10-04 |