Device Classification Name |
arthroscope |
|||
---|---|---|---|---|
510(k) Number | K991656 | |||
Device Name | AED ARTHROSCOPE | |||
Applicant |
|
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Applicant Contact | gayle m butler | |||
Correspondent |
|
|||
Correspodent Contact | gayle m butler | |||
Regulation Number | 888.1100 | |||
Classification Product Code |
|
|||
Date Received | 05/13/1999 | |||
Decision Date | 12/02/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Orthopedic |
|||
510k Review Panel |
General & Plastic Surgery |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |