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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vibration Threshold Measurement
510(k) Number K934368
Device Name NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
Applicant
Nk Biotechnical Engineering Co.
10850 Old County Rd. 15
Minneapolis,  MN  55441
Applicant Contact KAREN GOTFREDSON
Correspondent
Nk Biotechnical Engineering Co.
10850 Old County Rd. 15
Minneapolis,  MN  55441
Correspondent Contact KAREN GOTFREDSON
Regulation Number882.1200
Classification Product Code
LLN  
Date Received09/07/1993
Decision Date 08/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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