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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 K101791
Device Name ROSA SURGICAL DEVICE
Applicant
MEDTECH SAS
1006 RUE DE LA CROIX VERTE
PARC EUROMEDECINE (BAT8)
MONTPELLIER,  FR 34090
Applicant Contact BERTIN NAHUM
Correspondent
MEDTECH SAS
1006 RUE DE LA CROIX VERTE
PARC EUROMEDECINE (BAT8)
MONTPELLIER,  FR 34090
Correspondent Contact BERTIN NAHUM
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/28/2010
Decision Date 09/23/2010
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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