| Device Classification Name |
insufflator, laparoscopic |
|||
|---|---|---|---|---|
| 510(k) Number | K992381 | |||
| Device Name | CO2 GAS WARMER II, MODEL 6-800-00 | |||
| Applicant |
|
|||
| Applicant Contact | casey kurek | |||
| Correspondent |
|
|||
| Correspodent Contact | casey kurek | |||
| Regulation Number | 884.1730 | |||
| Classification Product Code |
|
|||
| Date Received | 07/16/1999 | |||
| Decision Date | 09/17/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Obstetrics/Gynecology |
|||
| 510k Review Panel |
Obstetrics/Gynecology |
|||
| summary |
summary |
|||
| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |