The following data is part of a premarket notification filed by North Bank Labs, Inc. with the FDA for Cold Roll.
| Device ID | K820901 |
| 510k Number | K820901 |
| Device Name: | COLD ROLL |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | NORTH BANK LABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-31 |
| Decision Date | 1982-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLD ROLL 98066542 not registered Live/Pending |
Cold Rolled Club, LLC 2023-06-30 |
![]() COLD ROLL 73356687 1295260 Dead/Cancelled |
North Bank Laboratories, Inc. 1982-03-26 |