The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Servotronic Ec100 System.
| Device ID | K962087 |
| 510k Number | K962087 |
| Device Name: | SERVOTRONIC EC100 SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | MEDICON, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein, Esq. |
| Correspondent | Howard M Holstein, Esq. MEDICON, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1997-04-23 |
| Summary: | summary |