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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Aneurysm
510(k) Number K844352
Device Name SUNDT-KEES REINFORCING ANEURYSM CLIP
Applicant
Kees Surgical Specialty Co., Inc.
104 N. St.
Wilder,  KY  41071
Applicant Contact GEORGE KEES
Correspondent
Kees Surgical Specialty Co., Inc.
104 N. St.
Wilder,  KY  41071
Correspondent Contact GEORGE KEES
Regulation Number882.5200
Classification Product Code
HCH  
Date Received11/09/1984
Decision Date 01/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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