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510(k) K864778

MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC by Mac Lee Medical Products — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1986
Date Received
December 8, 1986
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 Mac Lee Medical Products

  • K872953 — DISPOSABLE I.V. ADMINISTRATION SET (January 6, 1988)
  • 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)
  • 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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