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510(k) K945592

VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE by Vlv Associates, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
November 14, 1994
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 Vlv Associates, Inc.

  • K972957 — SA-EF MULTI-LUMEN EXTENSION SET (September 29, 1997)
  • K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET (February 28, 1997)
  • K955783 — VLV SA.EF INFUSION PORT EXTENSION SETS (February 7, 1996)
  • K953791 — VLV SA EF INFUSION PORT (October 30, 1995)
  • K940406 — DISPOSABLE, AMBULATORY, INFUSION PUMPS (September 2, 1994)
  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K922469 — PRO-LOK EXTENSION SET(S) (March 15, 1993)
  • K904217 — PRO-LOK (TM) EXTENSION SETS (October 3, 1990)
  • K901081 — PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY (June 8, 1990)
  • K901046 — VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (June 8, 1990)

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