| 510(k) Number |
K863516 |
| Device Name |
ELECTRONIC METAL LOCATOR MODEL MD-1 |
| Applicant |
| Advanced Instruments, Inc. |
| 1000 Highland Ave. |
|
Needham Heights,
MA
02194
|
|
| Applicant Contact |
DOUGLAS GUERETTE |
| Correspondent |
| Advanced Instruments, Inc. |
| 1000 Highland Ave. |
|
Needham Heights,
MA
02194
|
|
| Correspondent Contact |
DOUGLAS GUERETTE |
| Date Received | 09/09/1986 |
| Decision Date | 09/30/1986 |
| 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
|
|
|