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510(k) K003169

VASCULAR CLOSURE DEVICE by Std Mfg., Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2000
Date Received
October 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Std Mfg., Inc.

  • K023096 — CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM (April 10, 2003)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)
  • K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE (August 23, 2001)
  • K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM (March 7, 2000)
  • K930427 — STD IRRIGATION PUMP (June 1, 1993)

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