510(k) K853438 ยท HXA Prosthesis, Tendon, Passive
H-H HUNTER ACTIVE TENDON IMPLANT
| Applicant | Holter-Hausner Intl., Bridgeport PA, US |
| Decision | Substantially Equivalent for Some Indications, Sep 30, 1985 |
| Received | Aug 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853438
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.