Device Classification Name |
conserver, oxygen
|
510(k) Number |
K892639 |
Device Name |
THE ORIGINAL PULSE-PAK |
Applicant |
JONES SALES CO. |
4109 RAVINE DR. |
CANAL WINCHESTER,
OH
43110
|
|
Applicant Contact |
RUSSELL, SR. |
Correspondent |
JONES SALES CO. |
4109 RAVINE DR. |
CANAL WINCHESTER,
OH
43110
|
|
Correspondent Contact |
RUSSELL, SR. |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 04/12/1989 |
Decision Date | 10/05/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|