| Device Classification Name |
Laryngoscope, Rigid
|
| 510(k) Number |
K883819 |
| Device Name |
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P |
| Applicant |
| CIRCON ACMI |
| 300 STILLWATER AVE. |
| P.O. BOX 1971 |
|
STAMFORD,
CT
06904 -1971
|
|
| Applicant Contact |
TAYLOR, PE |
| Correspondent |
| CIRCON ACMI |
| 300 STILLWATER AVE. |
| P.O. BOX 1971 |
|
STAMFORD,
CT
06904 -1971
|
|
| Correspondent Contact |
TAYLOR, PE |
| Regulation Number | 868.5540 |
| Classification Product Code |
|
| Date Received | 09/08/1988 |
| Decision Date | 10/17/1988 |
| 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
|
|
|