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510(k) K130305

LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE by Lina Medical Aps — Product Code HIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2013
Date Received
February 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type

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Other clearances for product code HIN

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  • K113080 — TUBALGATOR (June 29, 2012)
  • K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP E (December 2, 2011)
  • K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (September 1, 2011)
  • K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.77 (April 16, 1999)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K926517 — ELMED LBC 50-P (November 15, 1994)
  • K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (November 3, 1994)