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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, autotransfusion
510(K) Number K122262
Model OPA-E-US
Device Name ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
Applicant
HAEMONETICS CORP.
400 wood rd
braintree,  MA  02184
Contact erica diaz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/27/2012
Decision Date 10/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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