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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 K790413
Device Name HEIFETZ ANEURYSM CLIP, LMM BLADE
Applicant
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5200
Classification Product Code
HCH  
Date Received02/26/1979
Decision Date 03/16/1979
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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