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 |