| 510(k) Number |
K852859 |
| Device Name |
PENNINE CONNECTING TUBING |
| Applicant |
| Pennine Medical , Ltd. |
| P.O. Box 648 |
|
Stoughton,
MA
02072
|
|
| Applicant Contact |
DAVID S LOCKE |
| Correspondent |
| Pennine Medical , Ltd. |
| P.O. Box 648 |
|
Stoughton,
MA
02072
|
|
| Correspondent Contact |
DAVID S LOCKE |
| Date Received | 07/05/1985 |
| Decision Date | 07/30/1985 |
| 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
|
|
|