The following data is part of a premarket notification filed by Jana Medical with the FDA for Laparoscopic Surgical Instrument.
Device ID | K924028 |
510k Number | K924028 |
Device Name: | LAPAROSCOPIC SURGICAL INSTRUMENT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | JANA MEDICAL RT. 507 BOX J Greentown, PA 18426 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-11 |
Decision Date | 1993-06-18 |