The following data is part of a premarket notification filed by Landec Corp. with the FDA for Quick-cast Immobilizer.
Device ID | K932507 |
510k Number | K932507 |
Device Name: | QUICK-CAST IMMOBILIZER |
Classification | Component, Cast |
Applicant | LANDEC CORP. 3603 HAVEN AVE. Menlo Park, CA 94025 |
Contact | Edmund F Byrne |
Correspondent | Edmund F Byrne LANDEC CORP. 3603 HAVEN AVE. Menlo Park, CA 94025 |
Product Code | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-25 |
Decision Date | 1994-02-23 |