Device Classification Name |
Airway, Oropharyngeal, Anesthesiology
|
510(k) Number |
K021634 |
Device Name |
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 |
Applicant |
KING SYSTEMS CORP. |
15011 HERRIMAN BLVD. |
NOBLESVILLE,
IN
46060
|
|
Applicant Contact |
TOM MCGRAIL |
Correspondent |
KING SYSTEMS CORP. |
15011 HERRIMAN BLVD. |
NOBLESVILLE,
IN
46060
|
|
Correspondent Contact |
TOM MCGRAIL |
Regulation Number | 868.5110
|
Classification Product Code |
|
Date Received | 05/17/2002 |
Decision Date | 01/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|