Device Classification Name |
table, operating-room, electrical
|
510(k) Number |
K853535 |
Device Name |
TRAUMA TABLE |
Applicant |
XRE CORP. |
300 FOSTER ST. |
LITTLETON,
MA
01460
|
|
Applicant Contact |
DONNA GLENCROSS |
Correspondent |
XRE CORP. |
300 FOSTER ST. |
LITTLETON,
MA
01460
|
|
Correspondent Contact |
DONNA GLENCROSS |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 08/23/1985 |
Decision Date | 09/11/1985 |
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
|