Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K113644 |
Device Name |
PILOT TUBE REPAIR KIT |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Applicant Contact |
DORIS F WALTER |
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Correspondent Contact |
DORIS F WALTER |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 12/12/2011 |
Decision Date | 01/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|