| Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
| 510(k) Number |
K931136 |
| Device Name |
APOLLO CAMERA |
| Applicant |
| Life Sensing Instrument Company, Inc. |
| 400 Long Beach Blvd. |
|
Stratford,
CT
06615
|
|
| Applicant Contact |
CURTIS RAYMOND |
| Correspondent |
| Life Sensing Instrument Company, Inc. |
| 400 Long Beach Blvd. |
|
Stratford,
CT
06615
|
|
| Correspondent Contact |
CURTIS RAYMOND |
| Regulation Number | 884.1720 |
| Classification Product Code |
|
| Date Received | 03/05/1993 |
| Decision Date | 01/11/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|