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510(k) K843617

SDC SILICONE SUMP DRAIN by Science Development Corp. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
September 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Science Development Corp.

  • K842491 — SDC SILICONE FORCEP SHODS PRODUCT (August 10, 1984)
  • K833355 — SDC VASCULAR TIES (January 27, 1984)
  • K832090 — SCD SKIN TEMP. SENSORS #3400 ETC (October 31, 1983)
  • K832392 — SDC ORAL-RECTAL TEMP. PROBE (September 12, 1983)
  • K832391 — QT-100 ELECTRONIC TEMP. MONITOR (September 12, 1983)
  • K830353 — ESOPHAGEAL PROBE W/TEMP. INDICATOR (April 6, 1983)
  • K830329 — ESOPHAGEAL STETHOSCOPE (March 11, 1983)
  • K830039 — SDC RECTAL TEMP. PROBE PRODUCT #1020 (February 23, 1983)

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  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)