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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 K940306
Device Name OCTOSTOP COMPENSATING FILTERS
Applicant
Octostop, Inc.
Casier Postal 1476
Succ. St-Laurent
Montreal, Qc.,  CA H4L 4Z1
Applicant Contact JEAN A VEZINA, M.D.
Correspondent
Octostop, Inc.
Casier Postal 1476
Succ. St-Laurent
Montreal, Qc.,  CA H4L 4Z1
Correspondent Contact JEAN A VEZINA, M.D.
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/12/1994
Decision Date 09/06/1994
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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