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 |