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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 K891993
Device Name COLLAGEN NEUROSPONGE
Applicant
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact SOPHIA PESOTCHINSKY
Correspondent
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact SOPHIA PESOTCHINSKY
Regulation Number882.4700
Classification Product Code
HBA  
Date Received03/28/1989
Decision Date 03/23/1990
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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