| 510(k) Number |
K844063 |
| Device Name |
SCISSORS GENERAL HOSPITAL |
| 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 |
| Date Received | 10/18/1984 |
| Decision Date | 11/19/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|