FDA 510(k), K060169, BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
FDA 510(k), K060169, BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
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510(K) Number: K060169
Device Name: BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
Manufacturer: BARRX MEDICAL, INCORPORATED
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 01/23/2006
Decision Date: 04/21/2006
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
Manufacturer: BARRX MEDICAL, INCORPORATED
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 01/23/2006
Decision Date: 04/21/2006
Regulation Medical Specialty: General & Plastic Surgery
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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