The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Various Arm Sling.
Device ID | K823808 |
510k Number | K823808 |
Device Name: | VARIOUS ARM SLING |
Classification | Sling, Arm |
Applicant | DANEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILI |
CFR Regulation Number | 890.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-17 |
Decision Date | 1983-01-14 |