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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cradle, Patient, Radiologic
510(k) Number K953246
Device Name OCTOROLL
Applicant
Octostop, Inc.
3575 Boul. St-Laurent
Bureau 401 Nt
Montreal, H2x2t7,  CA
Applicant Contact SYLVAIN BOUCHER
Correspondent
Octostop, Inc.
3575 Boul. St-Laurent
Bureau 401 Nt
Montreal, H2x2t7,  CA
Correspondent Contact SYLVAIN BOUCHER
Regulation Number892.1830
Classification Product Code
KXH  
Date Received07/11/1995
Decision Date 09/29/1995
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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