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FDA 510(k), K954035, ACTI-FLEX ARTERIAL EXTENSION SET
FDA 510(k), K954035, ACTI-FLEX ARTERIAL EXTENSION SET
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510(K) Number: K954035
Device Name: ACTI-FLEX ARTERIAL EXTENSION SET
Manufacturer: R-GROUP INTL.
Device Classification Name: arterial blood sampling kit
Regulation Number: 868.1100
Classification Product Code: CBT
Date Received: 08/28/1995
Decision Date: 09/25/1995
Regulation Medical Specialty: Anesthesiology
Device Name: ACTI-FLEX ARTERIAL EXTENSION SET
Manufacturer: R-GROUP INTL.
Device Classification Name: arterial blood sampling kit
Regulation Number: 868.1100
Classification Product Code: CBT
Date Received: 08/28/1995
Decision Date: 09/25/1995
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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