The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Universal Coupler, Laparoscopic Accessory.
| Device ID | K912247 |
| 510k Number | K912247 |
| Device Name: | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Contact | Robert I Rudko |
| Correspondent | Robert I Rudko LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-11-13 |