Device Classification Name |
table and attachments, operating-room
|
510(k) Number |
K925005 |
Device Name |
ISI SELF-SUPPORTING ARM |
Applicant |
INSTRUMENTATION SPECIALTIES, INC. |
32390 IH-10 WEST |
BOERNE,
TX
78006
|
|
Applicant Contact |
JOSEPH R KABANEK |
Correspondent |
INSTRUMENTATION SPECIALTIES, INC. |
32390 IH-10 WEST |
BOERNE,
TX
78006
|
|
Correspondent Contact |
JOSEPH R KABANEK |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 10/02/1992 |
Decision Date | 04/29/1993 |
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
|
|
|