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510(k) K841280

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO by Smith & Nephew, Mpl Division — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
March 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Smith & Nephew, Mpl Division

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  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K833304 — HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (March 30, 1984)
  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830524 — HENKE JECT PRESSURE SYRINGE (March 24, 1983)
  • K830242 — MICRO 2 HYPODERMIC NEEDLES (February 15, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

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  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
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  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)