Device Classification Name |
Tray, Surgical, Instrument
|
510(k) Number |
K854746 |
Device Name |
SURGICAL INSTRUMENT TRAY |
Applicant |
ZBI, INC. |
1138 WEST CHESTER PIKE, SUITE |
7 |
WEST CHESTER,
PA
19382
|
|
Applicant Contact |
MATTHEW H BROWN |
Correspondent |
ZBI, INC. |
1138 WEST CHESTER PIKE, SUITE |
7 |
WEST CHESTER,
PA
19382
|
|
Correspondent Contact |
MATTHEW H BROWN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/26/1985 |
Decision Date | 12/17/1985 |
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
|
|
|