The following data is part of a premarket notification filed by J-tech, Inc. with the FDA for Jtech 50 Series Cutting Loop.
| Device ID | K913587 |
| 510k Number | K913587 |
| Device Name: | JTECH 50 SERIES CUTTING LOOP |
| Classification | Resectoscope |
| Applicant | J-TECH, INC. 553 COBBLESTONE DR. Midvale, UT 84047 |
| Contact | Tracy Livingston |
| Correspondent | Tracy Livingston J-TECH, INC. 553 COBBLESTONE DR. Midvale, UT 84047 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-10-23 |