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510(k) K020470

MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE by Bypass , Ltd. — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
February 12, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Bypass , Ltd.

  • K011589 — CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD ( (December 26, 2001)

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