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510(k) K844306

GAINOR MEDICAL SYRINGE by Gainor Medical — Product Code FMF

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
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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)
  • K844305 — GAINOR MEDICAL FLOWMAX NEEDLES (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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