The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Laparoscopic Bladder Neck Suspension Kit.
| Device ID | K971797 |
| 510k Number | K971797 |
| Device Name: | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-15 |
| Decision Date | 1997-07-22 |
| Summary: | summary |