Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K972385 |
Device Name |
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED |
Applicant |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Applicant Contact |
TIMOTHY J TALCOTT |
Correspondent |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Correspondent Contact |
TIMOTHY J TALCOTT |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 06/26/1997 |
Decision Date | 01/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|