The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Laparotomy Bladder Neck Suspension Kit With Bone Anchors.
| Device ID | K971796 |
| 510k Number | K971796 |
| Device Name: | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | LOUISVILLE LABORATORIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane LOUISVILLE LABORATORIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EZL |
| Subsequent Product Code | HET |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-15 |
| Decision Date | 1997-08-12 |
| Summary: | summary |