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510(k) K061684

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME by Medi-Globe Corporation — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2006
Date Received
June 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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