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510(k) K091405

PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT by Given Imaging , Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2009
Date Received
May 12, 2009
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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  • DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (January 29, 2014)
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  • K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO (May 13, 2011)
  • K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (March 7, 2011)

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