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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: CLAMP, VASCULAR
Regulation Number: 870.4450
[See Other Products with this regulation number]
510(k) Number: K032589
Device Name: ENCLOSE II ANASTOMOSIS ASSIST DEVICE
Applicant: NOVARE SURGICAL SYSTEMS, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL, CA 94523 3389
Contact: DAVID W SCHLERF
Product Code: DXC
[See Other Manufacturers that make this Product]
Date Received: 08-22-2003
Decision Date: 09-05-2003
Decision: SE
Advisory Committee: CV
Statement/Summary/Purged Status: Summary
Type: Special
Review by Third Party: N
Expedited Review: N
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