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FDA 510(k), K020701, SYNCRUS INTERNAL CARDIOVERSION SYSTEM
FDA 510(k), K020701, SYNCRUS INTERNAL CARDIOVERSION SYSTEM
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510(K) Number: K020701
Device Name: SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Manufacturer: GUIDANT CORPORATION, CARDIAC SURGERY
Device Classification Name: electrode, pacing and cardioversion, temporary, epicardial
Regulation Number: 870.3680
Classification Product Code: NHW
Date Received: 03/04/2002
Decision Date: 05/24/2002
Regulation Medical Specialty: Cardiovascular
Device Name: SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Manufacturer: GUIDANT CORPORATION, CARDIAC SURGERY
Device Classification Name: electrode, pacing and cardioversion, temporary, epicardial
Regulation Number: 870.3680
Classification Product Code: NHW
Date Received: 03/04/2002
Decision Date: 05/24/2002
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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