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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurological stereotaxic instrument
510(k) Number K861629
Device Name KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
Applicant
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact JOHN FORSTER
Correspondent
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact JOHN FORSTER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/29/1986
Decision Date 08/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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