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510(k) K943679

UNIVEC NONRESUSABLE LOCKING SYRINGE by Univec, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1994
Date Received
July 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Univec, Inc.

  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
  • K993996 — UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE (July 17, 2000)
  • K000747 — UNIVEC TWO PIECE SYRINGE (June 8, 2000)
  • K961877 — PISTON SYRINGE (August 7, 1996)
  • K933469 — UNIVEC NON-REUSABLE SYRINGE (April 18, 1996)
  • K951619 — UNIVEC NONREUSABLE LOCKING SYRINGE (June 6, 1995)

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