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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, clinical color change
510(k) Number K110305
Device Name CRY-ACTRACKERCAM
Applicant
BRYMILL CRYOGENIC CYSTEMS
BUILDING 2, 105 WINDERMERE AVE
ELLINGTON,  CT  06029
Applicant Contact CLAUDIO RUSSO
Correspondent
BRYMILL CRYOGENIC CYSTEMS
BUILDING 2, 105 WINDERMERE AVE
ELLINGTON,  CT  06029
Correspondent Contact CLAUDIO RUSSO
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received02/02/2011
Decision Date 01/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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