The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Wet Pack Line Of Products.
Device ID | K820587 |
510k Number | K820587 |
Device Name: | WET PACK LINE OF PRODUCTS |
Classification | Lubricant, Patient |
Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMJ |
CFR Regulation Number | 880.6375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-04 |
Decision Date | 1982-03-26 |