Silastic II Mammary Implant
FDA 510(k) K801175 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK801175
Submission
- Device name
- Silastic II Mammary Implant
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Mchenry, IL, US - Received
- May 16, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
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Questions and answers
When was Silastic II Mammary Implant cleared by the FDA?
Silastic II Mammary Implant (K801175) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 216 days after the submission was received.