The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sav-a-limb.
| Device ID | K833872 |
| 510k Number | K833872 |
| Device Name: | SAV-A-LIMB |
| Classification | Bag, Ice |
| Applicant | SIL-MED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYR |
| CFR Regulation Number | 880.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-08 |
| Decision Date | 1984-02-04 |