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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 K902056
Device Name LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
Applicant
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number888.4220
Classification Product Code
JDY  
Date Received05/07/1990
Decision Date 10/30/1990
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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