CS 1200

Unit, Operative Dental

CARESTREAM HEALTH,INC.

The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Cs 1200.

Pre-market Notification Details

Device IDK112321
510k NumberK112321
Device Name:CS 1200
ClassificationUnit, Operative Dental
Applicant CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta,  GA  30339
ContactDaniel Hoefer
CorrespondentDaniel Hoefer
CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta,  GA  30339
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-12
Decision Date2011-11-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192156560070 K112321 000
60192156559999 K112321 000
60192155950438 K112321 000

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