The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Passive Tendon Implant.
| Device ID | K780320 |
| 510k Number | K780320 |
| Device Name: | PASSIVE TENDON IMPLANT |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-24 |
| Decision Date | 1978-03-17 |