Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
510(k) Number |
K964382 |
Device Name |
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) |
Applicant |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
CHYRELL SAUNDERS |
Correspondent |
GIBECK, INC. |
10640 EAST 59TH ST. |
P.O. BOX 36430 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
CHYRELL SAUNDERS |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 11/04/1996 |
Decision Date | 04/15/1997 |
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
|
|
|