The following data is part of a premarket notification filed by Plasti-products, Inc. with the FDA for E-z Open Dust Covers.
Device ID | K840595 |
510k Number | K840595 |
Device Name: | E-Z OPEN DUST COVERS |
Classification | Wrap, Sterilization |
Applicant | PLASTI-PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-09 |
Decision Date | 1984-03-19 |