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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, spinal-cord, implanted for peripheral vascular disease
510(k) Number K833430
Device Name BLOOD GAS EXPERSYSTEM 8700
Applicant
MEDICAL INTELCOM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICAL INTELCOM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Classification Product Code
LLE  
Date Received10/05/1983
Decision Date 02/10/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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