H-H Hunter Tendon Rod
FDA 510(k) K853437 · Holter-Hausner Intl.
510(k) numberK853437
Submission
- Device name
- H-H Hunter Tendon Rod
- Applicant
- Holter-Hausner Intl.
Bridgeport, PA, US - Received
- August 15, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Holter-Hausner Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K875287 | H-H Flushing ReservoirJXG · Traditional | 07/14/1988SE |
| K874508 | H-H External Ventricular Drainage Collection BagJXG · Traditional | 01/19/1988SE |
| K872293 | H-H Hunter Active Tendon Implant BCHXA · Traditional | 09/28/1987SN |
| K872285 | H-H Hunter Active Tendon Implant DCHXA · Traditional | 09/28/1987SN |
| K872284 | H-H Hunter Active Tendon Implant PCHXA · Traditional | 09/28/1987SN |
| K871351 | H-H Harris Neonatal Nasal Cannula Set for CPAPBZD · Traditional | 05/14/1987SE |
| K870660 | H-H External Ventricular Drain (Evd) Comp./SystemsJXG · Traditional | 05/01/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | 01/13/1987SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | 10/16/1985SE |
| K853438 | H-H Hunter Active Tendon ImplantHXA · Traditional | 09/30/1985SN |
Questions and answers
When was H-H Hunter Tendon Rod cleared by the FDA?
H-H Hunter Tendon Rod (K853437) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 62 days after the submission was received.