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510(k) K003511

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

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

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  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
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  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)