The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Implant, H.p. Condylar.
| Device ID | K781870 |
| 510k Number | K781870 |
| Device Name: | IMPLANT, H.P. CONDYLAR |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-03 |
| Decision Date | 1979-02-09 |