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FDA 510(k), K160974, Gammex Cut-Resistant Glove Liner
FDA 510(k), K160974, Gammex Cut-Resistant Glove Liner
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$149.00 USD
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510(K) Number: K160974
Device Name: Gammex Cut-Resistant Glove Liner
Manufacturer: ROBERT MAHLER
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: 04/07/2016
Date Received: 10/28/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Gammex Cut-Resistant Glove Liner
Manufacturer: ROBERT MAHLER
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: 04/07/2016
Date Received: 10/28/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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