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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Ultrasonic Instruments
510(k) Number K972612
Device Name DISSECTRON PORTABLE UNIT
Applicant
Satelec
70 Walnut St.
Wellesley,  MA  02481
Applicant Contact JACKIE MASSE
Correspondent
Satelec
70 Walnut St.
Wellesley,  MA  02481
Correspondent Contact JACKIE MASSE
Classification Product Code
LBK  
Date Received07/14/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
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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