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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 K073576
Device Name NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
Applicant
Harod Enterprises, Inc.
4052 Indian Creek Rd.
Martinez,  GA  30907
Applicant Contact NORRIS R HAROD
Correspondent
Harod Enterprises, Inc.
4052 Indian Creek Rd.
Martinez,  GA  30907
Correspondent Contact NORRIS R HAROD
Regulation Number882.4700
Classification Product Code
HBA  
Date Received12/19/2007
Decision Date 02/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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