The following data is part of a premarket notification filed by Impact Packaging Corp. with the FDA for Instant Ice Pack.
| Device ID | K901834 |
| 510k Number | K901834 |
| Device Name: | INSTANT ICE PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | IMPACT PACKAGING CORP. 770 SYCAMORE AVE. SUITE J-439 Vista, CA 92083 |
| Contact | Brian R Pike |
| Correspondent | Brian R Pike IMPACT PACKAGING CORP. 770 SYCAMORE AVE. SUITE J-439 Vista, CA 92083 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-05-03 |