The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Hunter Active Tendon Implant.
| Device ID | K853438 |
| 510k Number | K853438 |
| Device Name: | H-H HUNTER ACTIVE TENDON IMPLANT |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
| Contact | John R Bolles |
| Correspondent | John R Bolles HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-15 |
| Decision Date | 1985-09-30 |