The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor Fusion Funnel.
Device ID | K872281 |
510k Number | K872281 |
Device Name: | RAYLOR FUSION FUNNEL |
Classification | Spatula, Orthopedic |
Applicant | CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Contact | Qerry P Corbin |
Correspondent | Qerry P Corbin CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Product Code | HXR |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-16 |
Decision Date | 1987-11-02 |