Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K080170 |
Device Name |
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
SKIP RIMER |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
SKIP RIMER |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 01/24/2008 |
Decision Date | 03/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|