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FDA 510(k), K232295, LAA Exclusion System
FDA 510(k), K232295, LAA Exclusion System
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$271.74 USD
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510(K) Number: K232295
Device Name: LAA Exclusion System
Manufacturer: Syntheon, LLC
Device Classification Name: Left Atrial Appendage Clip, Implantable
Regulation Number: 878.4300
Classification Product Code: PZX
Date Received: 08/01/2023
Decision Date: 08/30/2023
Regulation Medical Specialty: General & Plastic Surgery
Total Pages: 171
Fully Redacted Pages: 93
Content Pages: 78
Device Name: LAA Exclusion System
Manufacturer: Syntheon, LLC
Device Classification Name: Left Atrial Appendage Clip, Implantable
Regulation Number: 878.4300
Classification Product Code: PZX
Date Received: 08/01/2023
Decision Date: 08/30/2023
Regulation Medical Specialty: General & Plastic Surgery
Total Pages: 171
Fully Redacted Pages: 93
Content Pages: 78
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