The following data is part of a premarket notification filed by Xylog Corp. with the FDA for Meditron Endolav Model El-100.
| Device ID | K882048 |
| 510k Number | K882048 |
| Device Name: | MEDITRON ENDOLAV MODEL EL-100 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1988-10-31 |