Device Classification Name |
Guide, Needle, Surgical
|
510(k) Number |
K923835 |
Device Name |
THE ELEVENTH FINGER |
Applicant |
GUARDIAN ANGEL PRODUCTS, INC. |
COLUMBIA SQUARE |
555 THIRTEETH STREET NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
GUARDIAN ANGEL PRODUCTS, INC. |
COLUMBIA SQUARE |
555 THIRTEETH STREET NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 07/31/1992 |
Decision Date | 07/09/1993 |
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
|
|
|