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510(k) K062753

FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC by Surgimed, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2007
Date Received
September 14, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Surgimed, Inc.

  • K851157 — SURGIMED - SURGICAL BLADES (April 25, 1985)
  • K840762 — SILVERTORQUE CEREBRAL CATHETER (July 13, 1984)
  • K840763 — SILVERTORQUE CARDIAC CATHETERS (June 13, 1984)
  • K840761 — SILVERTORQUE VISCERAL CATHETER (June 11, 1984)
  • K810689 — BALLOON CATHETER (July 28, 1981)

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