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510(k) K012362

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2001
Date Received
July 25, 2001
Clearance Type
Special
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)
  • K003169 — VASCULAR CLOSURE DEVICE (December 8, 2000)
  • K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM (March 7, 2000)
  • K930427 — STD IRRIGATION PUMP (June 1, 1993)

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