FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
510(k) Clearances
/ K801175
510(k) K801175
SILASTIC II MAMMARY IMPLANT by
Dow Corning Corp. Healthcare Industries Materials
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
May 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Dow Corning Corp. Healthcare Industries Materials
K853186
— SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
K844637
— WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
K850255
— DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 1985)
K843995
— TF-II HIP PROSTHESIS (April 23, 1985)
K842559
— WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
K840357
— SSA HIP PROSTHESIS (February 17, 1984)
K831479
— METAL-BACKED ACETABULAR CUP (June 15, 1983)
K812864
— SILASTIC VOICE PROSTHESIS (November 24, 1981)
K812053
— SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
K811679
— SILASTIC TENDON PASSER H.P. (July 10, 1981)