The following data is part of a premarket notification filed by Niti Medical Technologies Ltd. with the FDA for Laparoscopic Compression Anastomosis Clip (lapcac).
| Device ID | K043115 |
| 510k Number | K043115 |
| Device Name: | LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) |
| Classification | Clip, Implantable |
| Applicant | NITI MEDICAL TECHNOLOGIES LTD. 1 HATZORAN ST. P.O. BOX 8634 Netanya, IL 42506 |
| Contact | Orly Maor |
| Correspondent | Orly Maor NITI MEDICAL TECHNOLOGIES LTD. 1 HATZORAN ST. P.O. BOX 8634 Netanya, IL 42506 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-10 |
| Decision Date | 2004-12-01 |
| Summary: | summary |