The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Implant, Hinge Toe, Flex..
| Device ID | K780132 |
| 510k Number | K780132 |
| Device Name: | IMPLANT, HINGE TOE, FLEX. |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-24 |
| Decision Date | 1978-02-06 |