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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K003511
Device Name KENDALL-LTP TURNER SAVE-A-LINE
Applicant
The Ludlow Company LP
Two Ludlow Park
Chicopee,  MA  01022
Applicant Contact KATHLEEN M MURPHY
Correspondent
The Ludlow Company LP
Two Ludlow Park
Chicopee,  MA  01022
Correspondent Contact KATHLEEN M MURPHY
Regulation Number880.5680
Classification Product Code
FRP  
Date Received11/14/2000
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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