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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 K770690
Device Name MASK, VAPOR, MONOMER
Applicant
Howmedica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Howmedica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.4220
Classification Product Code
JDY  
Date Received04/13/1977
Decision Date 07/21/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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