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510(k) K791738

CUSTOM DRESSING CHANGE TRAYS by Sterile Design, Inc. — Product Code FMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1979
Date Received
August 30, 1979
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 Sterile Design, Inc.

  • K934688 — STERILE DESIGN (March 16, 1994)
  • K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
  • K842356 — CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
  • K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
  • K834239 — SDI C-FLEX STERILE LIGHT HANDLE (April 25, 1984)
  • K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
  • K813437 — PAN SET (December 31, 1981)

Other clearances for product code FMC

  • K042618 — LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BL (November 26, 2004)
  • 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)