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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 K994191
Device Name SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
Applicant
Nmt Medical, Inc.
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
Nmt Medical, Inc.
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact RONALD D ARKIN
Regulation Number882.4175
Classification Product Code
HCI  
Date Received12/13/1999
Decision Date 02/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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