The following data is part of a premarket notification filed by Medical Industries Packaging, Inc. with the FDA for Self-seal Sterilization Pouches.
Device ID | K832128 |
510k Number | K832128 |
Device Name: | SELF-SEAL STERILIZATION POUCHES |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | MEDICAL INDUSTRIES PACKAGING, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-01 |
Decision Date | 1983-08-08 |