The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Laparocopic Myoma Screw.
| Device ID | K915388 |
| 510k Number | K915388 |
| Device Name: | LAPAROCOPIC MYOMA SCREW |
| Classification | Screw, Fibroid, Gynecological |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | HHO |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002164918 | K915388 | 000 |