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510(k) K060109

OMI RETRACTABLE SAFETY SYRINGE by Vitalcare Group, Inc. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2006
Date Received
January 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Vitalcare Group, Inc.

  • K050906 — VITALCARE I.V. ADMINISTRATION SET (August 23, 2005)
  • 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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