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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, nerve conduction velocity measurement
510(k) Number K904165
Device Name SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT
Applicant
OCCUPATIONAL PREVENTIVE DIAGNOSTICS, INC.
AMBASSADOR 1, AIRPORT BUS. CTR
100 DIPLOMAT DRIVE
LESTER,  PA  19113
Applicant Contact CLIFTON, JR
Correspondent
OCCUPATIONAL PREVENTIVE DIAGNOSTICS, INC.
AMBASSADOR 1, AIRPORT BUS. CTR
100 DIPLOMAT DRIVE
LESTER,  PA  19113
Correspondent Contact CLIFTON, JR
Regulation Number882.1550
Classification Product Code
JXE  
Date Received09/11/1990
Decision Date 05/28/1991
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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