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510(k) K062786

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM by Given Imaging , Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2006
Date Received
September 18, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class
Class II
Regulation Number
876.1300
Review Panel
GU
Submission Type

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  • K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO (May 13, 2011)
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