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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name evacuator, vapor, cement monomer
510(k) Number K760906
Device Name MONOMER VAPOR CONTAINMENT SYSTEM
Original Applicant
HOWMEDICA CORP.
Regulation Number888.4220
Classification Product Code
JDY  
Date Received10/26/1976
Decision Date 11/11/1976
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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