The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor(tm) Drill Stop.
Device ID | K873692 |
510k Number | K873692 |
Device Name: | RAYLOR(TM) DRILL STOP |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
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 | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1987-12-17 |