The following data is part of a premarket notification filed by Wisebands Ltd. with the FDA for Wisebands Skin Closure Device.
| Device ID | K002315 |
| 510k Number | K002315 |
| Device Name: | WISEBANDS SKIN CLOSURE DEVICE |
| Classification | System, Skin Closure |
| Applicant | WISEBANDS LTD. P.O. BOX 978 Ra'anana, IL 43107 |
| Contact | Mary Page |
| Correspondent | Mary Page WISEBANDS LTD. P.O. BOX 978 Ra'anana, IL 43107 |
| Product Code | MKY |
| CFR Regulation Number | 878.4320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-31 |
| Decision Date | 2001-03-15 |