The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Exothermic Heating Pad.
| Device ID | K850637 |
| 510k Number | K850637 |
| Device Name: | EXOTHERMIC HEATING PAD |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-04-25 |