The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Trocar Disposable.
| Device ID | K904638 |
| 510k Number | K904638 |
| Device Name: | TROCAR DISPOSABLE |
| Classification | Trocar, Gastro-urology |
| Applicant | LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
| Contact | William J Przybyla |
| Correspondent | William J Przybyla LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
| Product Code | FBQ |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1991-02-21 |