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FDA 510(k), K010197, EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
FDA 510(k), K010197, EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
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510(K) Number: K010197
Device Name: EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
Manufacturer: ARMAND HAMID
Device Classification Name: Set, Administration, Intravascular
Regulation Number: FPA
Classification Product Code: KXA
Date Received: 01/22/2001
Decision Date: 05/14/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
Manufacturer: ARMAND HAMID
Device Classification Name: Set, Administration, Intravascular
Regulation Number: FPA
Classification Product Code: KXA
Date Received: 01/22/2001
Decision Date: 05/14/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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