The following data is part of a premarket notification filed by Kick Ice, Inc. with the FDA for Instant Hot Packs.
| Device ID | K963768 |
| 510k Number | K963768 |
| Device Name: | INSTANT HOT PACKS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | KICK ICE, INC. P.O. BOX 5519 EKS Johnson City, TN 37603 |
| Contact | Cynthia L Francis |
| Correspondent | Cynthia L Francis KICK ICE, INC. P.O. BOX 5519 EKS Johnson City, TN 37603 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1996-11-25 |
| Summary: | summary |