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510(k) K040821

COALESCENT SURGICAL U-CLIP AND ACCESSORIES by Coalescent Surgical — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2004
Date Received
March 30, 2004
Clearance Type
Traditional
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 Coalescent Surgical

  • K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (July 3, 2003)
  • K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (January 17, 2003)
  • K023125 — COALESCENT U-CLIP- AND ACCESSORIES (December 18, 2002)
  • K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (July 3, 2002)
  • K013664 — COALESCENT SURGICAL U-CLIP (January 24, 2002)
  • K012317 — COALESCENT SURGICAL U-CLIP (August 31, 2001)
  • K003958 — COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (February 6, 2001)
  • K994160 — COALESCENT SURGICAL SUTURED-CLIP (February 4, 2000)

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