FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SILASTIC II MAMMARY IMPLANT
K Number: K801175
·
Decision Dec 18, 1980
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
31
Review Days
216
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Basic Information
- Device Name
- SILASTIC II MAMMARY IMPLANT
- K Number
- K801175
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Date Received
- May 16, 1980
- Decision Date
- December 18, 1980
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K843995 | TF-II HIP PROSTHESIS | Apr 23, 1985 | Substantially Equivalent |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dec 20, 1984 | Substantially Equivalent |
| K840357 | SSA HIP PROSTHESIS | Feb 17, 1984 | Substantially Equivalent |
| K831479 | METAL-BACKED ACETABULAR CUP | Jun 15, 1983 | Substantially Equivalent |
| K812864 | SILASTIC VOICE PROSTHESIS | Nov 24, 1981 | Substantially Equivalent |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Aug 18, 1981 | Substantially Equivalent |
| K811679 | SILASTIC TENDON PASSER H.P. | Jul 10, 1981 | Substantially Equivalent |