The following data is part of a premarket notification filed by Efs Eberle Feinwerktechnische Systeme with the FDA for Eberle Shaver System C2 And Shaver Blades.
| Device ID | K061134 |
| 510k Number | K061134 |
| Device Name: | EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES |
| Classification | Arthroscope |
| Applicant | EFS EBERLE FEINWERKTECHNISCHE SYSTEME 731-733 SHOTGUN ROAD Ft. Lauderdale, FL 33326 |
| Contact | Gerald Goigitzer |
| Correspondent | Gerald Goigitzer EFS EBERLE FEINWERKTECHNISCHE SYSTEME 731-733 SHOTGUN ROAD Ft. Lauderdale, FL 33326 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2006-09-01 |
| Summary: | summary |