The following data is part of a premarket notification filed by Leebryan Intl. with the FDA for Mazing Heat Disposable Warm Pack.
| Device ID | K860444 |
| 510k Number | K860444 |
| Device Name: | MAZING HEAT DISPOSABLE WARM PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | LEEBRYAN INTL. P.O. BOX 152 Hampton, NJ 08827 |
| Contact | Peter J Fernandez |
| Correspondent | Peter J Fernandez LEEBRYAN INTL. P.O. BOX 152 Hampton, NJ 08827 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-02-27 |