FDA 510(k) K032688, COLONOSIGHT MODEL 510B, by Sightline Technologies , Ltd.
FDA 510(k) K032688, COLONOSIGHT MODEL 510B, by Sightline Technologies , Ltd.
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
510(k) Number: K032688
Device Name: COLONOSIGHT MODEL 510B
Applicant: Sightline Technologies , Ltd.
Regulation Number: 876.15
Classification Product Code: FDF
Date Received: 2003-08-29
Decision Date: 2004-03-05
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 479
Fully redacted pages: 389
Content pages: 90
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