| Device Classification Name |
Tourniquet, Nonpneumatic
|
| 510(k) Number |
K853472 |
| Device Name |
FINGER TOURNIQUETTE |
| Applicant |
| Joseph B. Marogil |
| Towers Medical Bldg. 515 |
| 21 Michigan St. NE |
|
Grand Rapids,
MI
49503
|
|
| Applicant Contact |
JOSEPH B MAROGIL |
| Correspondent |
| Joseph B. Marogil |
| Towers Medical Bldg. 515 |
| 21 Michigan St. NE |
|
Grand Rapids,
MI
49503
|
|
| Correspondent Contact |
JOSEPH B MAROGIL |
| Regulation Number | 878.5900 |
| Classification Product Code |
|
| Date Received | 08/20/1985 |
| Decision Date | 10/10/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|