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510(k) K050906

VITALCARE I.V. ADMINISTRATION SET by Vitalcare Group, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2005
Date Received
April 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Vitalcare Group, Inc.

  • K060109 — OMI RETRACTABLE SAFETY SYRINGE (May 5, 2006)
  • K040916 — VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (May 4, 2005)
  • K031748 — VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES (August 27, 2003)
  • K992289 — VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (August 4, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983716 — VITALCARE DISPOSABLE VAGINAL SPECULUM (December 23, 1998)
  • K982901 — LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED (December 21, 1998)

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