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510(k) K003956

BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 by C.R. Bard, Inc. — Product Code ODE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2001
Date Received
December 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

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