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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K982819
Device Name ENDIUS SPINE ENDOSCOPE
Applicant
Endius, Inc.
45 Pontiac Rd.
Newton,  MA  02468
Applicant Contact JOSEPH RESS
Correspondent
Endius, Inc.
45 Pontiac Rd.
Newton,  MA  02468
Correspondent Contact JOSEPH RESS
Regulation Number882.1480
Classification Product Code
GWG  
Date Received08/11/1998
Decision Date 01/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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