The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Ligating Clip.
| Device ID | K052018 |
| 510k Number | K052018 |
| Device Name: | MILTEX LIGATING CLIP |
| Classification | Clip, Implantable |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Charles Weaver |
| Correspondent | Charles Weaver MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-26 |
| Decision Date | 2005-11-04 |
| Summary: | summary |