| 510(k) Number |
K860022 |
| Device Name |
PARAGON MICRO-LOOPS |
| Applicant |
| Paragon Medical and Scientific, Inc. |
| 328 State St. |
|
Saint Paul,
MN
55107
|
|
| Applicant Contact |
TIMOTHY M SCANLAN |
| Correspondent |
| Paragon Medical and Scientific, Inc. |
| 328 State St. |
|
Saint Paul,
MN
55107
|
|
| Correspondent Contact |
TIMOTHY M SCANLAN |
| Date Received | 01/03/1986 |
| Decision Date | 03/24/1986 |
| 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
|
|
|