The following data is part of a premarket notification filed by K & L Ent. with the FDA for Re-heater, Hot Pack.
| Device ID | K863654 |
| 510k Number | K863654 |
| Device Name: | RE-HEATER, HOT PACK |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | K & L ENT. 15828 SOUTH BROADWAY, SUITE D Gardena, CA 90248 |
| Contact | Jeralynn Lowther |
| Correspondent | Jeralynn Lowther K & L ENT. 15828 SOUTH BROADWAY, SUITE D Gardena, CA 90248 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-10-23 |