The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Disposable Laparostat W/irrig & Aspir.
| Device ID | K912023 |
| 510k Number | K912023 |
| Device Name: | LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Donna Page |
| Correspondent | Donna Page LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-07 |
| Decision Date | 1991-06-11 |