The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Endoscopic Clip Sytem.
| Device ID | K080753 |
| 510k Number | K080753 |
| Device Name: | AESCULAP ENDOSCOPIC CLIP SYTEM |
| Classification | Clip, Implantable |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | FZP |
| Subsequent Product Code | DSS |
| Subsequent Product Code | GDO |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-04-02 |
| Summary: | summary |