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510(k) K801839

DISPOSABLE HYPODERMIC NEEDLES by Martin'S Maine Exchange — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 1, 1980
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 Martin'S Maine Exchange

  • K810008 — ALP-KII (January 16, 1981)
  • K801837 — PLASTIC STRIP BANDAGES (October 31, 1980)
  • K801840 — SURGICAL BANDAGES/SUNLEEP DX (September 9, 1980)

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