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510(k) K963504

MEDLINE OPEN END FINGER CONTROL MITT by Medline — Product Code FMQ

K963504 is an FDA 510(k) premarket notification submitted by Medline for the device "MEDLINE OPEN END FINGER CONTROL MITT". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Medline has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1996
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Protective
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Other clearances by Medline

  • K120156 — PUREIMAGE ULTRASOUND TRANSMISSION GEL (February 8, 2012)
  • K051378 — POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DR (August 3, 2005)
  • K010825 — MEDLINE STERISET STERILIZATION CONTAINER (May 8, 2001)
  • K990463 — MEDLINE EXCEL WHEELCHAIRS (March 15, 1999)
  • K970282 — MEDLINE CIRCUMCISION TRAY (March 6, 1997)
  • K963452 — MEDLINE ZIPPER SLEEVED VEST (October 18, 1996)
  • K951736 — LOCK-UP (July 5, 1995)
  • K932033 — LAPAROSCOPIC SURGERY INSTRUMENTS (June 19, 1995)
  • K932060 — MARTIN COLD LIGHT FOUNTAIN (March 30, 1994)
  • K915502 — MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES (April 29, 1992)

Other clearances for product code FMQ

  • K110377 — PROTECTIVE RESTRAINT (April 25, 2011)
  • K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (February 13, 2009)
  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)
  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 1999)
  • K982178 — VAGABOND SOFT RESTRAINT SYSTEM (January 26, 1999)
  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K972446 — PEDO CUSH PEDO CUDDLE (November 13, 1997)

FDA data resources