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FDA 510(k), K102274, ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
FDA 510(k), K102274, ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
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510(K) Number: K102274
Device Name: ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
Manufacturer: CURTIS RAYMOND
Device Classification Name: Needle, Aspiration And Injection, Disposable
Regulation Number: GAA
Classification Product Code: KXA
Date Received: 08/11/2010
Decision Date: 06/15/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
Manufacturer: CURTIS RAYMOND
Device Classification Name: Needle, Aspiration And Injection, Disposable
Regulation Number: GAA
Classification Product Code: KXA
Date Received: 08/11/2010
Decision Date: 06/15/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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