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510(k) K844305

GAINOR MEDICAL FLOWMAX NEEDLES by Gainor Medical — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1984
Date Received
November 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Gainor Medical

  • K850100 — BLOOD LANCET (January 29, 1987)
  • K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (February 21, 1985)
  • K844306 — GAINOR MEDICAL SYRINGE (November 30, 1984)
  • K840951 — FIRST AID BANDAGE (October 31, 1984)
  • K840950 — ZINC OXIDE TAPE (October 31, 1984)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K840947 — CLOTH-HYPOALLERGENIC (August 17, 1984)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)
  • K840949 — CLEAR PLASTIC-HYPOALLERGENIC (August 17, 1984)
  • K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC (August 14, 1984)

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