Home / 510(k) Clearances / K844637

510(k) K844637

WHITESIDE ACRYLIC CEMENT SPACER SLEEVE by Dow Corning Corp. Healthcare Industries Materials — Product Code LTC

K844637 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "WHITESIDE ACRYLIC CEMENT SPACER SLEEVE". The FDA issued a decision of Substantially Equivalent on June 19, 1985. The device falls under product code LTC (Hyaline Membrane Disease Assay), a Class III device. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1985
Date Received
November 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hyaline Membrane Disease Assay
Device Class
Class III
Regulation Number
Review Panel
CH
Submission Type

Other clearances by Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 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)
  • K801175 — SILASTIC II MAMMARY IMPLANT (December 18, 1980)

FDA data resources