| 510(k) Number |
K860618 |
| Device Name |
THRUST-AIRE MODEL 2001 |
| Applicant |
| Charron Industries, Inc. |
| P.O.Box 368 |
|
Hartford,
WI
53027
|
|
| Applicant Contact |
CHARLOTTE BICHEL |
| Correspondent |
| Charron Industries, Inc. |
| P.O.Box 368 |
|
Hartford,
WI
53027
|
|
| Correspondent Contact |
CHARLOTTE BICHEL |
| Date Received | 02/19/1986 |
| Decision Date | 04/10/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|