The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Bandbag, Wrap, Sterile.
Device ID | K820692 |
510k Number | K820692 |
Device Name: | BANDBAG, WRAP, STERILE |
Classification | Cover, Barrier, Protective |
Applicant | CONTOUR FABRICATORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | MMP |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-12 |
Decision Date | 1982-05-03 |