FDA 510(k), K934738, AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
FDA 510(k), K934738, AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
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510(K) Number: K934738
Device Name: AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
Manufacturer: PAUL D SMOLENSKI
Device Classification Name: Endoscopic Tissue Approximation Device
Regulation Number: OCW
Classification Product Code: 10/01/1993
Date Received: 03/16/1994
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
Manufacturer: PAUL D SMOLENSKI
Device Classification Name: Endoscopic Tissue Approximation Device
Regulation Number: OCW
Classification Product Code: 10/01/1993
Date Received: 03/16/1994
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
- 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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