Device Classification Name |
Motor, Surgical Instrument, Ac-Powered
|
510(k) Number |
K812437 |
Device Name |
150 DRIVER REAMER |
Applicant |
BLACK & DECKER(TM) |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BLACK & DECKER(TM) |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 08/26/1981 |
Decision Date | 11/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|