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510(k) K903347

SODIUM CHLORIDE SOLUTION by Superior Healthcare Group, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1990
Date Received
July 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Superior Healthcare Group, Inc.

  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR (March 15, 1993)
  • K905755 — NON-STERILE PATIENT EXAMINATION GLOVES (March 8, 1991)
  • K904216 — STERILE WATER SOLUTION CATALOG # 10000 (November 16, 1990)
  • K903340 — STERILE URETHRAL CATHETER PROCEDURE KITS (October 4, 1990)
  • K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (November 13, 1989)
  • K894676 — STERILE LATEX EXAM GLOVES (August 17, 1989)
  • K891445 — LATEX EXAMINATION GLOVES (August 9, 1989)
  • K892426 — NO. 86500 - ENDOSCOPIC JET WASHER (June 22, 1989)
  • K885339 — FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (March 1, 1989)

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