The following data is part of a premarket notification filed by Bypass Ltd. with the FDA for Modification To Corlink Automated Anastomotic Device.
| Device ID | K020470 |
| 510k Number | K020470 |
| Device Name: | MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE |
| Classification | Clip, Implantable |
| Applicant | BYPASS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BYPASS LTD. 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-03-08 |
| Summary: | summary |