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510(k) K090284

RES-Q INFANT WEDGE AND SLING by Cr Enterprises, LLC — Product Code FRP

K090284 is an FDA 510(k) premarket notification submitted by Cr Enterprises, LLC for the device "RES-Q INFANT WEDGE AND SLING". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code FRP (Holder, Infant Position), a Class I device regulated under 21 CFR 880.5680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
February 5, 2009
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 for product code FRP

  • K082367 — INFANT SLEEP BEANIE (June 12, 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)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)
  • 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