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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K853330
Device Name BOOMERANG ABSORPTION COMENSATION FILTER
Applicant
Entreprises Octostop, Inc.
C.P. 1476 St. Laurent
Montreal, Canada H4l 421,  CA
Applicant Contact JEAN A VEZINA
Correspondent
Entreprises Octostop, Inc.
C.P. 1476 St. Laurent
Montreal, Canada H4l 421,  CA
Correspondent Contact JEAN A VEZINA
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/08/1985
Decision Date 11/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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