| Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
| 510(k) Number |
K864883 |
| Device Name |
NEONATAL CANNULA CAP |
| Applicant |
| Behan & Taylor Ent. |
| 2611 Ann Arbor Ln. |
|
Bowie,
MD
20716
|
|
| Applicant Contact |
BEHAN LOISEL |
| Correspondent |
| Behan & Taylor Ent. |
| 2611 Ann Arbor Ln. |
|
Bowie,
MD
20716
|
|
| Correspondent Contact |
BEHAN LOISEL |
| Regulation Number | 868.5905 |
| Classification Product Code |
|
| Date Received | 12/12/1986 |
| Decision Date | 01/28/1987 |
| 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
|
|
|