The following data is part of a premarket notification filed by Sunmed, Inc. with the FDA for Orthoplug Soft Bone Design.
| Device ID | K955632 |
| 510k Number | K955632 |
| Device Name: | ORTHOPLUG SOFT BONE DESIGN |
| Classification | Cement Obturator |
| Applicant | SUNMED, INC. 3711 MEADOWVIEW DR., SUITE 100 Redding, CA 96002 |
| Contact | Ronald M Carn |
| Correspondent | Ronald M Carn SUNMED, INC. 3711 MEADOWVIEW DR., SUITE 100 Redding, CA 96002 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-02-27 |