| 510(k) Number |
K837200 |
| Device Name |
BRITT SURGICAL PHOTOCOAGULATOR SYSTEM |
| Applicant |
| Britt Corp., Inc. |
| 686 Old Willets Path |
|
Hauppauge,
NY
11788
|
|
| Correspondent |
| Britt Corp., Inc. |
| 686 Old Willets Path |
|
Hauppauge,
NY
11788
|
|
| Date Received | 01/24/1983 |
| Decision Date | 04/04/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|