The following data is part of a premarket notification filed by Medical Industries Packaging, Inc. with the FDA for Easy Breather Header Bags.
Device ID | K830961 |
510k Number | K830961 |
Device Name: | EASY BREATHER HEADER BAGS |
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 | 1983-03-25 |
Decision Date | 1983-04-12 |