| Device Classification Name |
Connector, Airway (Extension)
|
| 510(k) Number |
K954383 |
| Device Name |
SURELOC CIRCUIT CONNECTOR |
| Applicant |
| Polamedco, Inc. |
| 4054 Glencoe Ave. |
|
Marina Del Rey,
CA
90292 -5608
|
|
| Applicant Contact |
COREY SELMAN |
| Correspondent |
| Polamedco, Inc. |
| 4054 Glencoe Ave. |
|
Marina Del Rey,
CA
90292 -5608
|
|
| Correspondent Contact |
COREY SELMAN |
| Regulation Number | 868.5810 |
| Classification Product Code |
|
| Date Received | 09/19/1995 |
| Decision Date | 12/22/1995 |
| 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
|
|
|