Dow Corning Wright Titanium Wrist Joint Grommet
FDA 510(k) K850255 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK850255
Submission
- Device name
- Dow Corning Wright Titanium Wrist Joint Grommet
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Hemlock, MI, US - Received
- January 22, 1985
- Decision date
- May 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | 07/10/1981SE |
| K801175 | Silastic II Mammary Implant · Traditional | 12/18/1980SE |
Questions and answers
When was Dow Corning Wright Titanium Wrist Joint Grommet cleared by the FDA?
Dow Corning Wright Titanium Wrist Joint Grommet (K850255) received a 510(k) decision of Substantially Equivalent on May 1, 1985, 99 days after the submission was received.