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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 K914600
Device Name NEUROLOGICAL SPONGE
Applicant
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Applicant Contact BERNARD E LADERMAN
Correspondent
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Correspondent Contact BERNARD E LADERMAN
Regulation Number882.4700
Classification Product Code
HBA  
Date Received10/11/1991
Decision Date 12/30/1992
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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