The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Bone Plug H.p.(cement Restrict).
| Device ID | K800898 |
| 510k Number | K800898 |
| Device Name: | SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) |
| Classification | Nail, Fixation, Bone |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-18 |
| Decision Date | 1980-05-02 |