| Device Classification Name |
Bottle, Collection And Trap, Breathing System (Uncalibrated)
|
| 510(k) Number |
K760082 |
| Device Name |
BOTTLE, CONDENSATE (#1628) |
| Applicant |
| Inspiron Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Inspiron Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 06/21/1976 |
| Decision Date | 07/16/1976 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|