Device Classification Name |
Laryngoscope, Rigid
|
510(k) Number |
K062231 |
Device Name |
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 |
Applicant |
MINRAD, INC. |
847 MAIN ST. |
BUFFALO,
NY
14203
|
|
Applicant Contact |
JOHN MCNEIRNEY |
Correspondent |
MINRAD, INC. |
847 MAIN ST. |
BUFFALO,
NY
14203
|
|
Correspondent Contact |
JOHN MCNEIRNEY |
Regulation Number | 868.5540
|
Classification Product Code |
|
Date Received | 08/02/2006 |
Decision Date | 08/31/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|