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510(k) K955439

THE REEL THING (MODIFICATION) by Biomedical Devices, Inc. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1995
Date Received
November 13, 1995
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

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  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K830605 — PUMP PALL AMBULATORY INSULIN INFUSION (March 31, 1983)

Other clearances for product code GBX

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  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • 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)