Home / 510(k) Clearances / K003511

510(k) K003511

KENDALL-LTP TURNER SAVE-A-LINE by The Ludlow Company LP — Product Code FRP

K003511 is an FDA 510(k) premarket notification submitted by The Ludlow Company LP for the device "KENDALL-LTP TURNER SAVE-A-LINE". The FDA issued a decision of Substantially Equivalent on January 24, 2001. The device falls under product code FRP (Holder, Infant Position), a Class I device regulated under 21 CFR 880.5680. The Ludlow Company LP has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2001
Date Received
November 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

Other clearances by The Ludlow Company LP

  • K021132 — UNI-PATCH ULTRASOUND COUPLING GEL (May 15, 2002)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)

Other clearances for product code FRP

  • K082367 — INFANT SLEEP BEANIE (June 12, 2009)
  • K090284 — RES-Q INFANT WEDGE AND SLING (June 5, 2009)
  • K062143 — KOZY COMFORT INFANT POSITIONER (October 24, 2006)
  • K060986 — HEAD BED (July 11, 2006)
  • K051300 — ROBIN HOOD VEST (December 8, 2005)
  • K041996 — NIGHTFORM (August 3, 2004)
  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)

FDA data resources