Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K954828 |
FOIA Releasable 510(k) |
K954828
|
Device Name |
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT |
Applicant |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
BRIAN GRIGSBY |
Correspondent |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
BRIAN GRIGSBY |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 10/20/1995 |
Decision Date | 05/02/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|