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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K100495
Device Name PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
Applicant
PHILIPS ELECTRONICS UK LIMITED
LOWER ROAD
GLEMSFORD, SUFFOLK,  GB CO10 7QS
Applicant Contact MIRIAM SHARIF-MURRAY
Correspondent
PHILIPS ELECTRONICS UK LIMITED
LOWER ROAD
GLEMSFORD, SUFFOLK,  GB CO10 7QS
Correspondent Contact MIRIAM SHARIF-MURRAY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/19/2010
Decision Date 06/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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