The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Elmed Lbc 50-p.
| Device ID | K926517 |
| 510k Number | K926517 |
| Device Name: | ELMED LBC 50-P |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Contact | Werner Hausner |
| Correspondent | Werner Hausner ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1994-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B382SD52220 | K926517 | 000 |