The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Whiteside Acrylic Cement Spacer Sleeve.
| Device ID | K844637 |
| 510k Number | K844637 |
| Device Name: | WHITESIDE ACRYLIC CEMENT SPACER SLEEVE |
| Classification | Hyaline Membrane Disease Assay |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS Midland, MI 48640 |
| Contact | Harvey L Steinberg |
| Correspondent | Harvey L Steinberg DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS Midland, MI 48640 |
| Product Code | LTC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-28 |
| Decision Date | 1985-06-19 |