| Device Classification Name |
Esthesiometer
|
| 510(k) Number |
K871571 |
| Device Name |
NEUROTIPS(TM) |
| Applicant |
| Ulster Scientific, Inc. |
| P.O. Box 902 |
|
Highland,
NY
12528
|
|
| Applicant Contact |
ROBERT K MCEWEN |
| Correspondent |
| Ulster Scientific, Inc. |
| P.O. Box 902 |
|
Highland,
NY
12528
|
|
| Correspondent Contact |
ROBERT K MCEWEN |
| Regulation Number | 882.1500 |
| Classification Product Code |
|
| Date Received | 04/22/1987 |
| Decision Date | 06/18/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|