The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Or/cs Wrap.
| Device ID | K810646 |
| 510k Number | K810646 |
| Device Name: | OR/CS WRAP |
| Classification | Wrap, Sterilization |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, 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 | 1981-03-10 |
| Decision Date | 1981-03-20 |