The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Oxford External Fixation System.
Device ID | K800184 |
510k Number | K800184 |
Device Name: | OXFORD EXTERNAL FIXATION SYSTEM |
Classification | Component, Traction, Invasive |
Applicant | DOWNS SURGICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-29 |
Decision Date | 1980-02-11 |