The following data is part of a premarket notification filed by Efs Eberle Feinwerktechnische Systeme with the FDA for Eberle Shaver System Accessories.
Device ID | K092977 |
510k Number | K092977 |
Device Name: | EBERLE SHAVER SYSTEM ACCESSORIES |
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 | 2009-09-25 |
Decision Date | 2010-09-29 |
Summary: | summary |