The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Inflatable Bone Plug H.p..
| Device ID | K853186 |
| 510k Number | K853186 |
| Device Name: | SILASTIC INFLATABLE BONE PLUG H.P. |
| Classification | Cement Obturator |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS TECHNICAL SERVICE & DEVELOPMEN Hemlock, MI 48626 |
| Contact | Eldon E Frisch |
| Correspondent | Eldon E Frisch DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS TECHNICAL SERVICE & DEVELOPMEN Hemlock, MI 48626 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-09-24 |