The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Brand Penile Implant.
| Device ID | K780484 |
| 510k Number | K780484 |
| Device Name: | SILASTIC BRAND PENILE IMPLANT |
| Classification | Cannula, A-v Shunt |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-27 |
| Decision Date | 1978-07-17 |