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FDA 510(k), K100120, ALEXIS ORTHOPAEDIC WOUND RETRACTOR
FDA 510(k), K100120, ALEXIS ORTHOPAEDIC WOUND RETRACTOR
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$49.00 USD
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510(K) Number: K100120
Device Name: ALEXIS ORTHOPAEDIC WOUND RETRACTOR
Manufacturer: APPLIED MEDICAL RESOURCES CORP.
Device Classification Name: ring (wound protector), drape retention, internal
Regulation Number: 878.4370
Classification Product Code: KGW
Date Received: 01/15/2010
Decision Date: 04/02/2010
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ALEXIS ORTHOPAEDIC WOUND RETRACTOR
Manufacturer: APPLIED MEDICAL RESOURCES CORP.
Device Classification Name: ring (wound protector), drape retention, internal
Regulation Number: 878.4370
Classification Product Code: KGW
Date Received: 01/15/2010
Decision Date: 04/02/2010
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
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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