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510(k) K042901

ENDOMARK STERILE INDIA INK by Pmt Corp. — Product Code NBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
October 20, 2004
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

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Other clearances for product code NBG

  • K993951 — SPOT ENDOSCOPIC MARKER (February 18, 2000)