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510(k) K082367

INFANT SLEEP BEANIE by Life Innovations, LLC — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2009
Date Received
August 18, 2008
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

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  • 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)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)