Device Classification Name |
Operating Room Accessories Table Tray
|
510(k) Number |
K931037 |
Device Name |
WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) |
Applicant |
WHITMORE ENT., INC. |
RT. 5 BOX 369 |
SAN ANTONIO,
TX
78221
|
|
Applicant Contact |
EARL HARMSEN |
Correspondent |
WHITMORE ENT., INC. |
RT. 5 BOX 369 |
SAN ANTONIO,
TX
78221
|
|
Correspondent Contact |
EARL HARMSEN |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 03/01/1993 |
Decision Date | 07/30/1993 |
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
|