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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
510(k) Number K170003
Device Name Zip 4 Skin Closure Device
Applicant
ZipLine Medical, Inc.
747 Camden Ave, Suite A
Campbell,  CA  95008
Applicant Contact Trish Howell
Correspondent
ZipLine Medical Inc.
88 South Milton Avenue
Campbell,  CA  95008
Correspondent Contact Nancy Kaiser
Regulation Number880.5240
Classification Product Code
PYO  
Date Received01/03/2017
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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