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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 K962807
Device Name AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
Applicant
American Surgical Sponges
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
American Surgical Sponges
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number882.4700
Classification Product Code
HBA  
Date Received07/18/1996
Decision Date 05/02/1997
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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