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510(k) K031748

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES by Vitalcare Group, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2003
Date Received
June 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Vitalcare Group, Inc.

  • K060109 — OMI RETRACTABLE SAFETY SYRINGE (May 5, 2006)
  • K050906 — VITALCARE I.V. ADMINISTRATION SET (August 23, 2005)
  • K040916 — VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (May 4, 2005)
  • 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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