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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Vascular
510(k) Number K901303
Device Name HORIZON SURGICAL LIGATING AND MARKING CLIP
Applicant
Horizon Surgical, Inc.
P.O. Box 3460
Evergreen,  CO  80439
Applicant Contact FRANK N EASTERBROOK
Correspondent
Horizon Surgical, Inc.
P.O. Box 3460
Evergreen,  CO  80439
Correspondent Contact FRANK N EASTERBROOK
Regulation Number870.3250
Classification Product Code
DSS  
Date Received03/20/1990
Decision Date 06/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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