The following data is part of a premarket notification filed by New Dimensions In Medicine, Inc. with the FDA for Infant Electrosurgical Grounding Pad.
| Device ID | K780405 |
| 510k Number | K780405 |
| Device Name: | INFANT ELECTROSURGICAL GROUNDING PAD |
| Classification | Electrode, Electrosurgical |
| Applicant | NEW DIMENSIONS IN MEDICINE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-13 |
| Decision Date | 1978-04-05 |