The following data is part of a premarket notification filed by Medical Industries Packaging, Inc. with the FDA for Gas Sterilization Pouches.
Device ID | K821330 |
510k Number | K821330 |
Device Name: | GAS STERILIZATION POUCHES |
Classification | Wrap, Sterilization |
Applicant | MEDICAL INDUSTRIES PACKAGING, 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 | 1982-05-04 |
Decision Date | 1982-06-07 |