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FDA 510(k), K093296, ALEXIS LAPAROSCOPIC SYSTEM
FDA 510(k), K093296, ALEXIS LAPAROSCOPIC SYSTEM
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510(K) Number: K093296
Device Name: ALEXIS LAPAROSCOPIC SYSTEM
Manufacturer: APPLIED MEDICAL RESOURCES CORP.
Device Classification Name: ring (wound protector), drape retention, internal
Regulation Number: 878.4370
Classification Product Code: KGW
Date Received: 10/21/2009
Decision Date: 11/05/2009
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ALEXIS LAPAROSCOPIC SYSTEM
Manufacturer: APPLIED MEDICAL RESOURCES CORP.
Device Classification Name: ring (wound protector), drape retention, internal
Regulation Number: 878.4370
Classification Product Code: KGW
Date Received: 10/21/2009
Decision Date: 11/05/2009
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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