The following data is part of a premarket notification filed by Home Healthcare Products, Inc. with the FDA for Super-sorber.
Device ID | K780938 |
510k Number | K780938 |
Device Name: | SUPER-SORBER |
Classification | Garment, Protective, For Incontinence |
Applicant | HOME HEALTHCARE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-08 |
Decision Date | 1978-12-15 |