The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Disposable Electrosurgery Grounding Pad.
| Device ID | K984276 |
| 510k Number | K984276 |
| Device Name: | DISPOSABLE ELECTROSURGERY GROUNDING PAD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | E & M ENGINEERING, INC. 1705 DABNEY RD. Richmond, VA 23230 |
| Contact | Roger Strube |
| Correspondent | Roger Strube E & M ENGINEERING, INC. 1705 DABNEY RD. Richmond, VA 23230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-30 |
| Decision Date | 1999-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756142019 | K984276 | 000 |
| 50749756142002 | K984276 | 000 |