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510(k) K926517

ELMED LBC 50-P by Elmed, Inc. — Product Code HIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1994
Date Received
December 30, 1992
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

Other clearances by Elmed, Inc.

  • K010465 — DENSTAT (May 14, 2001)
  • K974793 — ELMED ESU 120 M/M DIGITAL (March 19, 1998)
  • K953271 — ELMED RF-ALERT (January 18, 1996)
  • K952110 — ELMED THERMO-FLUX (August 14, 1995)
  • K932938 — ELMED ESU 300 M/M AND DIGITAL (May 2, 1994)
  • K921770 — ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M (May 17, 1993)
  • K915731 — ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL (November 5, 1992)
  • K905417 — ELMED PNEUMOMAT DIGITAL (January 31, 1991)
  • K881431 — SIEMENS STEREODYNATOR 828 (April 16, 1990)
  • K875238 — SIEMENS NEUROTON 826 AND 827 (March 10, 1988)

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  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K943776 — COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (November 3, 1994)