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510(k) K993951

SPOT ENDOSCOPIC MARKER by Chek-Med Systems — Product Code NBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
November 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Colon
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Chek-Med Systems

  • K041783 — POLAR WAND (September 28, 2004)
  • K021387 — POLAR WAND (July 31, 2002)

Other clearances for product code NBG

  • K042901 — ENDOMARK STERILE INDIA INK (March 16, 2005)