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510(k) K911066

COMFORTRON PT (TENS) by M. D. Supply, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1992
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

Other clearances by M. D. Supply, Inc.

  • K925821 — COMFORTRON (May 7, 1993)
  • K862092 — COMFORTRON (October 15, 1986)

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