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510(k) K840620

TPN/CVP DRESSING CHANGE KIT by Marwood Medical, Inc. — Product Code FMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1984
Date Received
February 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
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)
  • K850339 — SPECIAL PROCEDURES PACK (March 12, 1985)
  • K850337 — CARDIAC CATHETERIZATION PACK (February 25, 1985)
  • K850341 — CARDIOVASCULAR SET UP (February 25, 1985)
  • K840619 — I.V. START KIT (March 27, 1984)

Other clearances for product code FMC

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  • K014134 — POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (January 22, 2002)
  • K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (August 17, 1999)
  • K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED) (May 18, 1994)
  • K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (May 18, 1994)
  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920649 — COMPASEP (July 23, 1992)
  • K915376 — GLASION VARNISH (January 22, 1992)
  • K905127 — LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (January 30, 1991)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)