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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name applier, aneurysm clip
510(k) Number K881912
Device Name SANO CLIP APPLIERS & REMOVERS
Applicant
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact JOHN D FORSTER
Correspondent
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact JOHN D FORSTER
Regulation Number882.4175
Classification Product Code
HCI  
Date Received05/09/1988
Decision Date 06/06/1988
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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