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510(k) K872953

DISPOSABLE I.V. ADMINISTRATION SET by Mac Lee Medical Products — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1988
Date Received
July 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Mac Lee Medical Products

  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)
  • K870995 — SCALP VEIN SET (July 31, 1987)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (December 29, 1986)
  • K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (December 29, 1986)
  • K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (December 29, 1986)
  • K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (December 29, 1986)
  • K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (December 23, 1986)
  • K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (December 23, 1986)
  • K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (December 23, 1986)
  • K841710 — MAC LEE VAGINAL IRRIGATOR (June 19, 1984)

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