Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 S. Milton Ave.
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
Predetermined Change
Control Plan Authorized		 No
-
-