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510(k) K943629

GIP/MEDI-GLOBE PAPILLOTOME by Medi-Globe Corp. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
July 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Medi-Globe Corp.

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  • K010714 — EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (January 21, 2003)
  • K010549 — BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (January 18, 2002)
  • K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM (March 31, 1999)
  • K953355 — GIP/MEID-GLOBE HOT BIOPSY FORCEPS (April 4, 1996)
  • K955558 — GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES (February 29, 1996)
  • K953827 — GIP/MEDI-GLOBE ERCP CATHETERS (September 1, 1995)
  • K941973 — GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES (June 30, 1995)

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