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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K092239
Device Name ROSA SURGICAL DEVICE, MODEL ROSA 1.1
Applicant
MEDTECH S.A.
1006 RUE DE LA CROIX VERTE
PARC EUROMEDICINE (BAT 8)
MONTPELLIER,  FR 34090
Applicant Contact BERTIN NAHUM
Correspondent
MEDTECH S.A.
1006 RUE DE LA CROIX VERTE
PARC EUROMEDICINE (BAT 8)
MONTPELLIER,  FR 34090
Correspondent Contact BERTIN NAHUM
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/23/2009
Decision Date 11/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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