The following data is part of a premarket notification filed by Kenpak Converters, Inc. with the FDA for Mdt Chemitest See-thru Bag.
| Device ID | K831425 |
| 510k Number | K831425 |
| Device Name: | MDT CHEMITEST SEE-THRU BAG |
| Classification | Wrap, Sterilization |
| Applicant | KENPAK CONVERTERS, 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 | 1983-05-03 |
| Decision Date | 1983-06-02 |