The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Servotronic Ec100 System.
| Device ID | K972857 |
| 510k Number | K972857 |
| Device Name: | SERVOTRONIC EC100 SYSTEM |
| Classification | Motor, Drill, Electric |
| Applicant | MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-01 |
| Decision Date | 1998-01-16 |
| Summary: | summary |