The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Raylor Bone Impactors.
| Device ID | K863415 |
| 510k Number | K863415 |
| Device Name: | RAYLOR BONE IMPACTORS |
| Classification | Instrument, Surgical, Non-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 | HAO |
| CFR Regulation Number | 882.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-09-24 |