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510(k) K972839

PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET by Globe Ent., Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
August 1, 1997
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 Globe Ent., Inc.

  • K972854 — PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMIN (December 17, 1997)
  • K972843 — PROTOS BLOOD TRANSFUSION SET (December 16, 1997)
  • K892623 — PATIENT EXAMINATION GLOVES (LATEX) (September 11, 1989)
  • K884622 — SURGICAL GLOVES (March 14, 1989)

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