The following data is part of a premarket notification filed by Zipline Medical, Inc. with the FDA for Zip 4 Skin Closure Device.
| Device ID | K170003 |
| 510k Number | K170003 |
| Device Name: | Zip 4 Skin Closure Device |
| Classification | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use |
| Applicant | ZipLine Medical, Inc. 747 Camden Ave, Suite A Campbell, CA 95008 |
| Contact | Trish Howell |
| Correspondent | Nancy Kaiser ZipLine Medical Inc. 88 South Milton Avenue Campbell, CA 95008 |
| Product Code | PYO |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-08-18 |
| Summary: | summary |