The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Vaginal Suturing Kit For Bladder Neck Suspension.
| Device ID | K971802 |
| 510k Number | K971802 |
| Device Name: | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-15 |
| Decision Date | 1997-07-30 |
| Summary: | summary |