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510(k) K850339

SPECIAL PROCEDURES PACK by Marwood Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
January 28, 1985
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 Marwood Medical, Inc.

  • K850340 — EYE PROCEDURE PACK (May 22, 1985)
  • K850338 — EMERGENCY ROOM PACK (March 25, 1985)
  • K850337 — CARDIAC CATHETERIZATION PACK (February 25, 1985)
  • K850341 — CARDIOVASCULAR SET UP (February 25, 1985)
  • K840620 — TPN/CVP DRESSING CHANGE KIT (May 30, 1984)
  • K840619 — I.V. START KIT (March 27, 1984)

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