| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K850111 |
| Device Name |
AIRES TUOHY NEEDLES 17GA. X 4 1/2 |
| Applicant |
| Aries Medical, Inc. |
| Two Gill St. |
|
Woburn,
MA
01801
|
|
| Applicant Contact |
MICHAEL RISHTON |
| Correspondent |
| Aries Medical, Inc. |
| Two Gill St. |
|
Woburn,
MA
01801
|
|
| Correspondent Contact |
MICHAEL RISHTON |
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 01/14/1985 |
| Decision Date | 01/24/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|