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FDA 510(k), K040836, DISPOSABLE OVERTUBE
FDA 510(k), K040836, DISPOSABLE OVERTUBE
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510(K) Number: K040836
Device Name: DISPOSABLE OVERTUBE
Manufacturer: GRETCHEN Y COHEN
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: FED
Classification Product Code: KXA
Date Received: 03/31/2004
Decision Date: 06/10/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DISPOSABLE OVERTUBE
Manufacturer: GRETCHEN Y COHEN
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: FED
Classification Product Code: KXA
Date Received: 03/31/2004
Decision Date: 06/10/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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