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510(k) K914384

MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE by Medical Design & Manufacturing Corp. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
October 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Medical Design & Manufacturing Corp.

  • K911911 — MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM (March 20, 1992)
  • K911366 — PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE (September 27, 1991)
  • K902822 — MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE (December 19, 1990)
  • K895604 — SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (October 13, 1989)
  • K880492 — INTERCEPT T.E.N.S. DEVICE (April 18, 1988)
  • K834138 — HYPO SUTURE (January 27, 1984)
  • K821848 — ASSURE-MALE EXTERNAL INCONTINCE CATHETER (August 10, 1982)
  • K811224 — MINISTIM (June 2, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)

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