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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 K950647
Device Name ULTRACELL NEURO SPONGES
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Applicant Contact GEORGE P KORTEWEG
Correspondent
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Correspondent Contact GEORGE P KORTEWEG
Regulation Number882.4700
Classification Product Code
HBA  
Date Received02/13/1995
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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