The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for Nikopad Electrosurgical Grounding Pad, Model 4777m.
| Device ID | K000079 |
| 510k Number | K000079 |
| Device Name: | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M |
| Classification | Apparatus, Electrosurgical |
| Applicant | NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-11 |
| Decision Date | 2000-02-04 |