510(k) K170003
- Device
- Zip 4 Skin Closure Device
- Applicant
- ZipLine Medical, Inc.
- 510(k) number
- K170003
- Product code
- PYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-18
- Date received
- 2017-01-03
- Regulation
- 880.5240
- Classification name
- Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Trish Howell
- Address
- 747 Camden Ave. Suite A Campbell CA US 95008 95008
FDA Registration Numbers#
- 1319454
- 3011656357
- 3017896419
- 3017859599
- 1121142
- 3009993798
- 1250045
- 3031582449
- 3006943846
- 3008808560
- 3010202439
- 2024024
- 9710641
- 2951231
- 3011270181
- 3024524151
- 3017178899
- 3031569206
- 2020550
- 3004713654
- 3023855650
- 3024891479
- 3015545156
- 3011568703
- 3011814545
- 3017210336
- 3014342096
- 3031288561
- 3016615875
- 3029933740
- 3020776832
- 3015341499
- 3035374295
- 3025349205
- 2523928
- 1526534
- 3031582434
- 9611594
- 3005083505
- 1218386
- 3009486864
- 3030226294
- 1062379
- 3024548814
- 1526012
- 3030692786
- 3005273623
- 2027009
Source Documents#
Legacy Summary#
summary
FDA Review#
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