The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Bulk Tissue Removal System.
| Device ID | K924844 |
| 510k Number | K924844 |
| Device Name: | BULK TISSUE REMOVAL SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-10-08 |