Device Classification Name |
Motor, Surgical Instrument, Ac-Powered
|
510(k) Number |
K961901 |
Device Name |
BONE & MARROW COLLECTION SYSTEM |
Applicant |
BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 |
SAN ANTONIO,
TX
78245
|
|
Applicant Contact |
W. CASEY FOX |
Correspondent |
BIOMEDICAL ENT., INC. |
14785 OMICRON DR., SUITE 205 |
SAN ANTONIO,
TX
78245
|
|
Correspondent Contact |
W. CASEY FOX |
Regulation Number | 878.4820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/1996 |
Decision Date | 08/06/1996 |
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
|
|
|