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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 K902167
Device Name CONTAIN(TM) LASER PLUME FILTER
Applicant
Arbor Technologies, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Applicant Contact DAWN I MOORE
Correspondent
Arbor Technologies, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Correspondent Contact DAWN I MOORE
Regulation Number888.4220
Classification Product Code
JDY  
Date Received05/15/1990
Decision Date 01/04/1991
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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