The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (typically).
| Device ID | K993306 |
| 510k Number | K993306 |
| Device Name: | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) |
| Classification | Apparatus, Electrosurgical |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan, M.s.m.e., Rac |
| Correspondent | Elaine Duncan, M.s.m.e., Rac PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-11-03 |
| Summary: | summary |