The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Laparoscopic Bone Anchored Urethropexy Instrument Tray.
| Device ID | K963076 |
| 510k Number | K963076 |
| Device Name: | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Contact | David Phelps |
| Correspondent | David Phelps LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Product Code | HET |
| Subsequent Product Code | EZL |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-04-04 |