Device Classification Name |
kit, surgical instrument, disposable
|
510(k) Number |
K920763 |
Device Name |
LACERATTION TRAY |
Applicant |
STERILE CONCEPTS, INC. |
5100 COMMERCE RD.. |
RICHMOND,
VA
23234
|
|
Applicant Contact |
KAY ANDREWS |
Correspondent |
STERILE CONCEPTS, INC. |
5100 COMMERCE RD.. |
RICHMOND,
VA
23234
|
|
Correspondent Contact |
KAY ANDREWS |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/19/1992 |
Decision Date | 09/28/1992 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|