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510(k) K964401

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) by Ludlow Technical Products — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

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  • K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (August 21, 1997)
  • K931903 — SURELOCK(TM) SNAPLESS MONITORING ELECTRODE (October 7, 1993)

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