The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Dow Corning/w Right Wound Drainage Sys.
| Device ID | K800014 |
| 510k Number | K800014 |
| Device Name: | DOW CORNING/W RIGHT WOUND DRAINAGE SYS |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-04 |
| Decision Date | 1980-01-17 |