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FDA 510(k), K103253, SILS PORT
FDA 510(k), K103253, SILS PORT
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510(K) Number: K103253
Device Name: SILS PORT
Manufacturer: TIM M LOHNES
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: KXA
Date Received: 11/03/2010
Decision Date: 02/24/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SILS PORT
Manufacturer: TIM M LOHNES
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: KXA
Date Received: 11/03/2010
Decision Date: 02/24/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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