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FDA 510(k), K163548, ENSEAL X1 Large Jaw Tissue Sealer
FDA 510(k), K163548, ENSEAL X1 Large Jaw Tissue Sealer
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$89.00 USD
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510(K) Number: K163548
Device Name: ENSEAL X1 Large Jaw Tissue Sealer
Manufacturer: Marjorie Medina
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 12/16/2016
Decision Date: 02/14/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ENSEAL X1 Large Jaw Tissue Sealer
Manufacturer: Marjorie Medina
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 12/16/2016
Decision Date: 02/14/2017
Decision: Substantially Equivalent (SESE)
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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