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510(k) K780470

H.P. MEDICAL GRADE SILICONE TUBING by Dow Corning Corp. Healthcare Industries Materials — Product Code KDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1978
Date Received
March 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Dow Corning Corp. Healthcare Industries Materials

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  • 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)

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  • K121618 — BEL-GEN COLD STORAGE SOLUTION (June 14, 2013)
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  • K043461 — CUSTODIOL (February 28, 2005)