The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Hammertoe Implant (swanson-well.
| Device ID | K801094 |
| 510k Number | K801094 |
| Device Name: | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-08 |
| Decision Date | 1980-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420198068 | K801094 | 000 |
| 00840420132727 | K801094 | 000 |
| 00840420132734 | K801094 | 000 |
| 00840420132741 | K801094 | 000 |
| 00840420132758 | K801094 | 000 |
| 00840420132765 | K801094 | 000 |
| 00840420132772 | K801094 | 000 |
| 00840420198044 | K801094 | 000 |
| 00840420198051 | K801094 | 000 |
| 00840420132710 | K801094 | 000 |