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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K920567
Device Name MODELS 3987 AND 3988 RESUME LEAD FOR PNS
Applicant
MEDTRONIC VASCULAR
7000 central ave. n.e.
minneapolis,  MN  55432
Applicant Contact daryle petersen
Correspondent
MEDTRONIC VASCULAR
7000 central ave. n.e.
minneapolis,  MN  55432
Correspondent Contact daryle petersen
Regulation Number882.5870
Classification Product Code
GZF  
Date Received02/07/1992
Decision Date 05/20/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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