The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor(tm) Mallet.
| Device ID | K864422 |
| 510k Number | K864422 |
| Device Name: | RAYLOR(TM) MALLET |
| Classification | Impactor |
| 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 | HWA |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-10 |
| Decision Date | 1986-11-24 |