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510(k) K870995

SCALP VEIN SET by Mac Lee Medical Products — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1987
Date Received
March 11, 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

  • K872953 — DISPOSABLE I.V. ADMINISTRATION SET (January 6, 1988)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)
  • K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (December 29, 1986)
  • K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (December 29, 1986)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (December 29, 1986)
  • K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (December 29, 1986)
  • K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (December 23, 1986)
  • K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (December 23, 1986)
  • K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (December 23, 1986)
  • K841710 — MAC LEE VAGINAL IRRIGATOR (June 19, 1984)

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