The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor(tm) Protective Retractor.
Device ID | K864424 |
510k Number | K864424 |
Device Name: | RAYLOR(TM) PROTECTIVE RETRACTOR |
Classification | Retractor |
Applicant | CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Contact | Terry P Corbin |
Correspondent | Terry P Corbin CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-10 |
Decision Date | 1986-11-26 |