The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Compression System.
Device ID | K831076 |
510k Number | K831076 |
Device Name: | COMPRESSION SYSTEM |
Classification | Device, Fixation, Proximal Femoral, Implant |
Applicant | KIRSCHNER MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDO |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-04 |
Decision Date | 1983-04-28 |