| 510(k) Number |
K841668 |
| Device Name |
CO2 LAPAROSCOPE |
| Applicant |
| Laser Spectrum, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Laser Spectrum, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 04/23/1984 |
| Decision Date | 04/23/1984 |
| Decision |
SE - Postmarket Surveillance Required
(SESP) |
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|