The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Electrosurgial Instruments.
| Device ID | K932654 |
| 510k Number | K932654 |
| Device Name: | ELECTROSURGIAL INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Donald Barham |
| Correspondent | Donald Barham MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1994-02-22 |