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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 K862509
Device Name CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
Applicant
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact MIKE BARBOUR
Correspondent
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact MIKE BARBOUR
Regulation Number888.4220
Classification Product Code
JDY  
Date Received07/01/1986
Decision Date 07/23/1986
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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