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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K120378
Models 2970-KA, 2971-KA, 2972-KA, 2973-KA, 2974-KA,2975-KA, 915-KA
Device Name PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
Original Applicant
KURARAY MEDICAL INC.
ote center bldg.
7f, 1-1-3, otemachi
chiyoda-ku,  JA 100-0004
Original Contact michio takigawa
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/08/2012
Decision Date 03/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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