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FDA 510(k), K983067, FINE-JECT
FDA 510(k), K983067, FINE-JECT
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510(K) Number: K983067
Device Name: FINE-JECT
Manufacturer: HENKE SASS WOLF OF AMERICA, INC.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 09/02/1998
Decision Date: 10/30/1998
Regulation Medical Specialty: General Hospital
Device Name: FINE-JECT
Manufacturer: HENKE SASS WOLF OF AMERICA, INC.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 09/02/1998
Decision Date: 10/30/1998
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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