The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor Retractors.
Device ID | K853796 |
510k Number | K853796 |
Device Name: | RAYLOR RETRACTORS |
Classification | Retractor |
Applicant | CEDAR SURGICAL, INC. 11 CHARLES LAKE RD. North Oaks, MN 55110 |
Contact | Fred S Halverson |
Correspondent | Fred S Halverson CEDAR SURGICAL, INC. 11 CHARLES LAKE RD. North Oaks, MN 55110 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-11 |
Decision Date | 1985-10-07 |