The following data is part of a premarket notification filed by Guardian Products Co., Inc. with the FDA for Bathtub Grab Bar.
Device ID | K821009 |
510k Number | K821009 |
Device Name: | BATHTUB GRAB BAR |
Classification | Adaptor, Hygiene |
Applicant | GUARDIAN PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILS |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-12 |
Decision Date | 1982-04-21 |