The following data is part of a premarket notification filed by New England Medical, Inc. with the FDA for New England Medical Grounding Pad.
| Device ID | K931982 |
| 510k Number | K931982 |
| Device Name: | NEW ENGLAND MEDICAL GROUNDING PAD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEW ENGLAND MEDICAL, INC. 111 WASHINGTON ST. ROUTE 1 Plainville, MA 02762 |
| Contact | James A Berry |
| Correspondent | James A Berry NEW ENGLAND MEDICAL, INC. 111 WASHINGTON ST. ROUTE 1 Plainville, MA 02762 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-10-05 |