The following data is part of a premarket notification filed by W.g. Whitney Corp. with the FDA for Cold/hot Pack.
| Device ID | K803299 |
| 510k Number | K803299 |
| Device Name: | COLD/HOT PACK |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | W.G. WHITNEY CORP. 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 | 1980-12-30 |
| Decision Date | 1981-01-15 |