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510(k) K831964

CMS 2000 SERIES TPN KITS by Currie Medical Specialties, Inc. — Product Code FMC

K831964 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "CMS 2000 SERIES TPN KITS". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code FMC (Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
June 17, 1983
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 Currie Medical Specialties, Inc.

  • K151158 — ALP VasQcare Take Home System (December 10, 2015)
  • K143317 — Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (January 20, 2015)
  • K140092 — CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) (April 16, 2014)
  • K112311 — ALP 501 RB PUMP SYSTEM (September 1, 2011)
  • K902441 — DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (August 23, 1990)
  • K874760 — CK 4900 SERIES, GOWN AND TOWEL PAK (December 10, 1987)
  • K872395 — CK 1600 SERIES, TOWELS (July 2, 1987)
  • K871737 — CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (June 22, 1987)
  • K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (January 8, 1987)
  • K864697 — CK 6000 SERIES, TOWELS (December 18, 1986)

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)
  • K932404 — NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (May 18, 1994)
  • K932405 — NITRILE RUBBER EXAMINATION GLOVES (POWERED) (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)

FDA data resources