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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: KXA
Date Received: 10/01/1993
Decision Date: 03/16/1994
Decision: 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: KXA
Date Received: 10/01/1993
Decision Date: 03/16/1994
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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