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FDA 510(k), K110004, ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
FDA 510(k), K110004, ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
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510(K) Number: K110004
Device Name: ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
Manufacturer: JONATHAN KAHAN
Device Classification Name: Laparoscopic Single Port Access Device
Regulation Number: OTJ
Classification Product Code: 01/03/2011
Date Received: 01/26/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
Manufacturer: JONATHAN KAHAN
Device Classification Name: Laparoscopic Single Port Access Device
Regulation Number: OTJ
Classification Product Code: 01/03/2011
Date Received: 01/26/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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