The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Laparoscopic Laser Fiber Diverter.
| Device ID | K912502 |
| 510k Number | K912502 |
| Device Name: | LAPAROSCOPIC LASER FIBER DIVERTER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Lisa M Scholz |
| Correspondent | Lisa M Scholz UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-05 |
| Decision Date | 1991-07-25 |