Device Classification Name |
hemostat
|
510(k) Number |
K844152 |
Device Name |
HEMSTATS |
Applicant |
I M, INC. |
P.O. BOX 658 |
FAIRFIELD,
NJ
07004
|
|
Applicant Contact |
BERNARD E LADERMAN |
Correspondent |
I M, INC. |
P.O. BOX 658 |
FAIRFIELD,
NJ
07004
|
|
Correspondent Contact |
BERNARD E LADERMAN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/24/1984 |
Decision Date | 11/07/1984 |
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
|
|
|