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510(k) K964661

HX-20/21-1 ENDOSCOPIC LIGATOR by Olympus America, Inc. — Product Code MND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1997
Date Received
November 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

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Other clearances for product code MND

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  • K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (October 7, 2005)
  • K031236 — AUTO-BAND LIGATOR (November 14, 2003)
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  • K022434 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (August 5, 2002)
  • K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (December 11, 2001)
  • K001744 — OLYMPUS ENDOSCOPIC LIGATION DEVICE (February 27, 2001)
  • K990864 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (June 11, 1999)