The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor(tm) Depth Gauge.
Device ID | K864426 |
510k Number | K864426 |
Device Name: | RAYLOR(TM) DEPTH GAUGE |
Classification | Gauge, Depth |
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 | HTJ |
CFR Regulation Number | 888.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-10 |
Decision Date | 1986-11-26 |