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FDA 510(k), K980755, B-D E ML PEN
FDA 510(k), K980755, B-D E ML PEN
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510(K) Number: K980755
Device Name: B-D E ML PEN
Manufacturer: PETER ZURLO
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: KXA
Date Received: 02/25/1998
Decision Date: 04/02/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: B-D E ML PEN
Manufacturer: PETER ZURLO
Device Classification Name: Syringe, Piston
Regulation Number: FMF
Classification Product Code: KXA
Date Received: 02/25/1998
Decision Date: 04/02/1998
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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