The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Brand Percutaneous Skin Expande.
| Device ID | K801042 |
| 510k Number | K801042 |
| Device Name: | SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE |
| Classification | Expander, Skin, Inflatable |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-02 |
| Decision Date | 1980-06-26 |