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510(k) K911911

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM by Medical Design & Manufacturing Corp. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1992
Date Received
April 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Medical Design & Manufacturing Corp.

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  • K895604 — SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (October 13, 1989)
  • K880492 — INTERCEPT T.E.N.S. DEVICE (April 18, 1988)
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  • K821848 — ASSURE-MALE EXTERNAL INCONTINCE CATHETER (August 10, 1982)
  • K811224 — MINISTIM (June 2, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)

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