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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, silk
510(k) Number K180701
Device Name SafePath Suturing System
Applicant
SafePath Medical, Inc.
21 Water Street - 5th Floor
Amesbury,  MA  01913
Applicant Contact Howard L. Schrayer
Correspondent
SafePath Medical, Inc.
21 Water Street - 5th Floor
Amesbury,  MA  01913
Correspondent Contact Howard L. Schrayer
Regulation Number878.5030
Classification Product Code
GAP  
Subsequent Product Code
GAB  
Date Received03/16/2018
Decision Date 06/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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