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510(k) K880492

INTERCEPT T.E.N.S. DEVICE by Medical Design & Manufacturing Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
February 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Medical Design & Manufacturing Corp.

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  • 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)
  • 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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