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510(k) K963453

CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) by Contour Fabricators, Inc. — Product Code FMQ

K963453 is an FDA 510(k) premarket notification submitted by Contour Fabricators, Inc. for the device "CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Contour Fabricators, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 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 Contour Fabricators, Inc.

  • K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
  • K970900 — INSTRUMENT HOLDER (May 22, 1997)
  • K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
  • K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER (April 10, 1997)
  • K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
  • K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
  • K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

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