The following data is part of a premarket notification filed by J.j. Consulting Services, Inc. with the FDA for Um-d3000/um-d4000.
| Device ID | K963985 |
| 510k Number | K963985 |
| Device Name: | UM-D3000/UM-D4000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | J.J. CONSULTING SERVICES, INC. 14719 S.W. 112 TERR Miami, FL 33196 |
| Contact | Annie Velez |
| Correspondent | Annie Velez J.J. CONSULTING SERVICES, INC. 14719 S.W. 112 TERR Miami, FL 33196 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1996-12-27 |