The following data is part of a premarket notification filed by Jana Medical with the FDA for Laparoscopic Surgical Instrumetns.
| Device ID | K921260 |
| 510k Number | K921260 |
| Device Name: | LAPAROSCOPIC SURGICAL INSTRUMETNS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | JANA MEDICAL RT. 507 BOX J Greentown, PA 18426 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-16 |
| Decision Date | 1992-07-13 |