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510(k) K103736

DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE by Dmc Medical, Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
December 22, 2010
Clearance Type
Traditional
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 Dmc Medical, Ltd.

  • K992932 — CIPA (ADULTS) CIPI (INFANTS) (June 7, 2000)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)

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