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 |