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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K770894
Device Name NEURO-SORB PATTIES
Applicant
INSTRANETICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRANETICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.4700
Classification Product Code
HBA  
Date Received05/16/1977
Decision Date 06/20/1977
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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