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FDA 510(k), K083146, ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
FDA 510(k), K083146, ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
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510(K) Number: K083146
Device Name: ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Manufacturer: ASAHI INTECC CO., LTD.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 10/23/2008
Decision Date: 11/21/2008
Regulation Medical Specialty: Cardiovascular
Device Name: ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Manufacturer: ASAHI INTECC CO., LTD.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 10/23/2008
Decision Date: 11/21/2008
Regulation Medical Specialty: Cardiovascular
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