The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Scleral Sponge Ii W/circling Bd.
| Device ID | K800140 |
| 510k Number | K800140 |
| Device Name: | SILASTIC SCLERAL SPONGE II W/CIRCLING BD |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-21 |
| Decision Date | 1980-03-03 |