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510(k) K840321

ENDODYNE DUAL by Elmed, Inc. — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
January 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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  • 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)

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