| Device Classification Name |
Airway, Nasopharyngeal
|
| 510(k) Number |
K871673 |
| Device Name |
NASOPHARYNGEAL AIRWAY |
| Applicant |
| Harding Industries, Inc. |
| 166 Ridgedale Ave. P.O. Box |
| 2119 |
|
Morristown,
NJ
07960
|
|
| Applicant Contact |
FRANK V GOODWIN |
| Correspondent |
| Harding Industries, Inc. |
| 166 Ridgedale Ave. P.O. Box |
| 2119 |
|
Morristown,
NJ
07960
|
|
| Correspondent Contact |
FRANK V GOODWIN |
| Regulation Number | 868.5100 |
| Classification Product Code |
|
| Date Received | 04/28/1987 |
| Decision Date | 06/15/1987 |
| 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
|
|
|